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Riverain ClearRead +Confirm Highlights Lines and Tubes on Chest X-rays

Riverain ClearRead +Confirm Highlights Lines and Tubes on Chest X-rays

Riverain ClearRead +Confirm Highlights Lines and Tubes on Chest X-rays

Software that increases visibility, decreases time to confirm placement of lifesaving medical devices receives CE mark.

New software by Riverain Technologies that improves the visual clarity of conventional chest X-ray images and increases radiologists’ efficiency by reducing the time it takes to accurately confirm the proper placement of lifesaving feeding, drug-delivery and pain management tubes and lines has received CE Mark approval.

The software, ClearRead +Confirm™, will be introduced at the 2012 Radiological Society of North America (RSNA) annual meeting in Chicago.

Tubes and lines placed inside the body are used regularly for intensive care patients and others receiving ongoing treatments for cancer, pain and other conditions. Improper placement or migration of the devices between uses can cause serious complications, including death.

Portable chest X-ray machines are routinely used to confirm placement of lines and tubes; however, the image quality makes it challenging for radiologists to differentiate these structures, and the rib and clavicle bones obscure visibility of chest tissue by up to 40 percent. Radiologists also incur significant time adjusting the image to make the edges and tips of the devices stand out.

ClearRead +Confirm™ software immediately processes any portable chest X-ray, creating a second, soft tissue image with the ribs and clavicles suppressed and increasing the contrast, sharpness and visibility of tubes, lines and cardiac wires. Radiologists simply toggle between the two images to confidently and efficiently confirm proper placement of the devices.

A Georgetown University reader study assessed the time it took radiologists to locate:

PICC lines, or peripherally inserted central catheters, which are long, thin tubes that remain inside the chest to deliver nutrients, fluid, blood, and medicines over time to treat pain, infection or cancer. PICC lines also are used to draw blood samples and provide kidney dialysis.

Nasogastric tubes (NG tubes), which carry food and medicine to the stomach through the nose.

Wires that conduct or measure electrical impulses, including electrodes for cardiac pacing and defibrillation.

In the study, 334 chest X-rays were reviewed by 10 radiologists with and without the enhanced ClearRead +Confirm image. The software reduced the reading time by an average of nearly 19 percent, without comprising accuracy.

Evaluating the conventional X-ray and ClearRead image together took an average of 5 ½ seconds less per image than evaluating the conventional X-ray image on its own, amounting to a savings of 30 minutes across all images.

Participating radiologists strongly agreed that the enhanced image increased their confidence in confirming the placement of lines and tubes and made it easier to see venous catheters.

“The software-enhanced chest X-ray image increases radiologists’ confidence while reducing decision-making time and time to treatment, with no additional tests or radiation exposure for patients,” said Steve Worrell, Riverain’s Chief Technology Officer.

ClearRead +Confirm uses the clinically proven, proprietary machine learning and pattern recognition technologies in Riverain’s chest X-ray bone-suppression and computer-aided detection (CAD) software.

ClearRead +Confirm software is cleared for sale in Europe and is currently being reviewed for clearance by the FDA.

For a demonstration or additional information, visit the Riverain Technologies booth at RSNA 2012 (#5917, South Building, Hall A)

ClearRead +Confirm is software that identifies and highlights lines and tubes on portable chest X-ray images while maintaining excellent image quality. Since diagnostic quality is preserved, radiologists can minimize imaging adjustments and decrease reading time. With ClearRead +Confirm, radiologists reduced portable reading time by approximately 19% without compromising accuracy or confidence.

Approved for sale in Europe. Pending 510(k), not available for sale within the United States

Riverain Technologies is introducing its ClearRead +Confirm software at RSNA, a package that improves the visual clarity of conventional chest X-ray images by highlighting tubes and lines that might otherwise be very hard to see. ICU patients typically have many tubes and lines going into the body, and chest X-rays acquired with portable X-ray machines are often used to determine proper placement of devices in order to avoid complications.

Image quality is often suboptimal, and the rib and clavicle bones obscure visibility of chest tissue making it hard to interpret the image. ClearRead +Confirm processes the radiograph, creating a second soft tissue image with the ribs and clavicles suppressed and increasing the contrast, sharpness and visibility of tubes, lines and cardiac wires. To achieve this, the software uses the same proprietary machine learning and pattern recognition technologies as employed in Riverain’s chest X-ray bone-suppression and computer-aided detection (CAD) software.

In a study evaluating the effect of the software on reading time, 334 chest X-rays were reviewed by 10 radiologists with and without the enhanced ClearRead +Confirm image. Reading time was reduced by nearly 19 percent, and readers were more confident of their findings. ClearRead +Confirm has received CE Mark approval and is under review by the FDA.

Source : http://www.riveraintech.com/confirmapproval/

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Blue Medical’s Protégé NC Non-Compliant Drug Eluting Balloon Cleared in EU

Blue Medical’s Protégé NC Non-Compliant Drug Eluting Balloon Cleared in EU

Blue Medical’s Protégé NC Non-Compliant Drug Eluting Balloon Cleared in EU

Non compliant PTCA balloons are commonly used to post-dilatate stents and to treat in stent restenosis (ISR). With the introduction of Drug Eluting Balloons medication was added to PTCA balloon treatment. But the need for precise and powerful dilatation remained. With Protégé NC Blue Medical succeeded in combining safe and reproducible drug delivery with the proven treatmentadvantages of a non compliant balloon..

Blue Medical, the global medical device company and innovator in the treatment of vascular diseases, today announced receiving the CE mark for Protégé NC, a non compliant drug eluting balloon. The new device will be launched worldwide. It follows the introduction of Blue Medical’s CE marked Drug Eluting Balloon Protégé and CoCr Stent on Drug Eluting Balloon Pioneer in March of this year. Blue Medical will continue to develop their novel DEB technologies into additional applications both for coronary and peripheral application.

Non compliant PTCA balloons are commonly used to post-dilatate stents and to treat in stent restenosis (ISR). With the introduction of Drug Eluting Balloons medication was added to PTCA balloon treatment. But the need for precise and powerful dilatation remained. “Combining a drug eluting balloon with the characteristics of the proven treatment advantages of a non compliant balloon is a logical next step” said Ronald Horvers, Blue Medical’s CTO and CFO. “With Protégé NC we succeeded in combining safe and reproducible drug delivery with precise and powerful dilatation in one device. Thus reducing on the one hand procedural costs and post procedural medication requirements and at the same time increasing procedure efficiency, safety and patients comfort. In addition to these advantages the performance, profile and flexibility of a normal workhorse PTCA balloon are maintained, making the device easy to work with.”

“This new non compliant DEB completes the coronary drug eluting product line of Blue Medical”, said Noel Coopmans, CEO. “It’s another landmark in the company’s history of developing unique and innovative products. I trust it will contribute to the further growth of Blue Medical in the years ahead”.

About Blue Medical

Located in the Dutch Brainport Area, Blue Medical develops, manufactures and markets innovative medical products for vascular diseases. Founded in 1998 the company has created a respected history of innovative ideas translated into high-end products and technologies used in different kinds of vascular products. Several patented technologies are licensed or sold to partners and now serve their products for patients care. Every year, over 100.000 patients are treated with Blue Medical devices worldwide.

Blue Medical (Helmond, The Netherlands) received CE Mark approval for its Protégé NC non compliant drug eluting balloon. It’s used to post-dilatate stents and to treat in stent restenosis.

Paclitaxel is embedded in the balloon’s hydrophilic coating that is only released once the balloon makes contact with the vessel wall.

More about the balloon from the announcement:

With the introduction of Drug Eluting Balloons medication was added to PTCA balloon treatment. But the need for precise and powerful dilatation remained. “Combining a drug eluting balloon with the characteristics of the proven treatment advantages of a non compliant balloon is a logical next step” said Ronald Horvers, Blue Medical’s CTO and CFO. “With Protégé NC we succeeded in combining safe and reproducible drug delivery with precise and powerful dilatation in one device. Thus reducing on the one hand procedural costs and post procedural medication requirements and at the same time increasing procedure efficiency, safety and patients comfort. In addition to these advantages the performance, profile and flexibility of a normal workhorse PTCA balloon are maintained, making the device easy to work with.”

source : http://www.bluemedical.com/press-release/press-release-protege-nc

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AeriSeal Foam for Emphysema Now on Trial

AeriSeal Foam for Emphysema Now on Trial

AeriSeal Foam for Emphysema Now on Trial

Aeris, from Woburn, MA, has received CE approval for its Aeriseal system for treating emphysema. The Aeriseal system works by reducing the lung volume in order to improve lung function by improving the ventilation-perfusion mismatch. This is done by delivering a sealing foam to diseased areas of the lung during bronchoscopy. In the weeks after the treatment, air trapped in the sealed part of the lung is gradually absorbed and the area collapses. The space that arises is filled by adjacent lung tissue, allowing it to function more effectively. The procedure is an alternative to the more invasive lung volume reduction surgery which is only used in the most advanced cases of the disease and has a high percentage of complications. Several trials are underway assessing the effectiveness of the new system.

Researchers at the University of Alabama at Birmingham injected a foam sealant into the lungs of a former smoker on Oct. 29, 2012, to treat his worsening emphysema. He was the first patient in the United States treated in a late-stage clinical trial of the AeriSeal System. The therapy, approved for use in parts of Europe and Israel, is undergoing investigation in the U.S. as a potential method of reducing lung volume in patients with severe emphysema.

Emphysema, a lung disease usually caused by smoking, damages air sacs in the lung called alveoli. The sacs fill with air that the body is unable to exhale, causing the lungs to expand. This in turn flattens the diaphragm, the primary muscle used for breathing. The flattened diaphragm is unable to function properly, making it extremely difficult for the individual to breathe. An estimated 4.9 million Americans have been diagnosed with emphysema.

A treatment known as lung volume reduction surgery has been employed to treat emphysema with some success. In the procedure, diseased portions of the lungs are surgically removed, allowing the lungs to return to a more normal size. This in turn allows the diaphragm to resume normal function. However, lung volume reduction surgery comes with substantial risk, including a 50 percent risk of major cardiac or pulmonary complications.

“We have been in search of a less-invasive way to achieve the same goal of lung reduction, without the risks inherent in surgery,” says Mark Dransfield, M.D., associate professor in the division of Pulmonary, Allergy and Critical Care Medicine and primary investigator in the new study.

The AeriSeal System treatment is performed via a standard bronchoscopy, in which a bronchoscope is used to thread a catheter through the patient’s airway to the most diseased areas of the lung. The foam, a proprietary polymer, comes in two liquid parts which are mixed together moments before injection. The addition of air to the mixture produces the foam. Within about 30 minutes of injection, the foam hardens to a rubbery consistency, blocking off the holes in the air sacs and causing sealing the damaged regions of lung. Over the course of several weeks, the air sacs deflate and the lung shrinks in size, clearing the way for the diaphragm to return to normal function.

“Based on previous studies and experience overseas, the AeriSeal System appears to be nearly as effective as lung volume reduction surgery without the more significant risks of surgery,” says Dransfield. “The main side effect of this therapy is an immune system inflammatory response with flu-like symptoms that resolves over the course of two or three days.”

UAB is part of an international phase III trial of the AeriSeal System treatment, aiming to enroll 300 patients in Europe, Israel and the United States.

In recent years, lung volume reduction surgery (LVRS) has become an accepted therapy for patients with advanced emphysema. LVRS involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This invasive surgical procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

The AeriSeal System was developed to achieve lung volume reduction using a minimally invasive approach and without the attendant risks of LVRS. With AeriSeal System therapy, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient’s lungs. The treatment delivers a proprietary Foam Sealant designed to seal and collapse the treatment area, thereby reducing lung volume. Reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively, thereby improving breathing function and quality of life in patients with advanced emphysema.

The University of Alabama at Birmingham is reporting that it’s the first in the U.S., as part of a late-stage clinical trial, to use the AeriSeal System as a treatment for emphysema. Developed by Aeris out of Woburn, MA, the AeriSeal is used to deliver foam to diseased areas of the lungs, reducing lung volume and addressing the ventilation-perfusion mismatch.

The polymer foam is initially composed of two components that are mixed along with air and injected with help from a bronchoscope. It takes about 30 minutes for the foam to harden and seal off the diseased pulmonary subsegments. Following the procedure, the treated areas slowly collapse and lung volume is reduced.

“We have been in search of a less-invasive way to achieve the same goal of lung reduction, without the risks inherent in surgery,” says Mark Dransfield, M.D., associate professor in the division of Pulmonary, Allergy and Critical Care Medicine and primary investigator in the new study.

“Based on previous studies and experience overseas, the AeriSeal System appears to be nearly as effective as lung volume reduction surgery without the more significant risks of surgery,” says Dransfield. “The main side effect of this therapy is an immune system inflammatory response with flu-like symptoms that resolves over the course of two or three days.”

Source : http://aerist.com/aeriseal-system/

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CareFusion announces new products to help improve medication safety

CareFusion announces new products to help improve medication safety

Today at the 2012 American Society of Health-System Pharmacists (ASHP) Midyear Meeting & Exhibition, CareFusion Corp. (NYSE: CFN), a leading, global medical technology company, announced multiple new products that are designed to help improve medication safety.

“Our enterprise-wide approach to medication safety extends beyond device hardware to provide valuable information that helps improve safety and workflow efficiency,” said Tom Leonard, president of Medical Systems at CareFusion. “Never in our history have we had stronger or more innovative technologies to help clinicians keep patients safe and help lower hospital costs.”

New offerings being showcased at CareFusion booth #1949 include:

Pyxis® ES platform (Pyxis® Anesthesia ES system, Pyxis MedStation® ES system, Pyxis® Enterprise Server)

Pyxis® Anesthesia ES system with Pyxis Enterprise Server: The Pyxis Anesthesia ES system is the newest offering available on the Pyxis ES platform, following last year’s introduction of the Pyxis MedStation® ES system. This innovative solution extends the value of the Pyxis ES Platform to the operating room (OR) and procedural areas for a single hospital or across a health system. Powered by the Pyxis Enterprise Server, the Pyxis Anesthesia ES system offers the same innovative centralized system management and enterprise-wide capabilities as the Pyxis MedStation ES system, including enhanced formulary and user management for pharmacy and improved system management for information technology (IT) departments. Redesigned from the ground up, Pyxis Anesthesia ES system provides simple, safe patient-centric workflows and security enhancements that promote hospital compliance efforts and help protect patients, anesthesia providers and pharmacy personnel.

Pyxis MedStation® ES system with Pyxis Enterprise Server: Introduced in 2011, this new system features centralized system management capabilities not previously seen in other medication management systems. New integration capabilities with existing hospital systems provide one system formulary and enhanced user management across the health system. The system also provides patient-centric clinical workflow efficiencies with an improved user interface that provides comprehensive medication information in one place.

Pyxis® Anesthesia system 4000: Built with identical hardware as the Pyxis Anesthesia ES system, this new dispensing system automates medication management in the operating room and procedural areas and helps maximize medication security and storage capacity with an advanced biometric access system and a variety of drawer types—including a new controlled access drawer for larger high-risk medications like propofol. The system electronically captures information on medication removals, wastes and charges, reducing time-consuming manual tasks. Because it uses identical hardware as the Pyxis Anesthesia ES system, the Pyxis Anesthesia system 4000 provides the foundation for future migration to the Pyxis ES platform.

Alaris® Infusion Viewer for Pharmacy Logistics: This web-based dashboard is capable of showing near real-time status of all infusions across a hospital or health system that is using the Alaris® System with the Alaris Pump and/or Alaris Syringe Modules. The Alaris Infusion Viewer for Pharmacy Logistics uses data that is wirelessly transmitted from the pumps to display if infusions are currently infusing, stopped or completed. It can also show how much time remains and the amount of medication volume that is left to be infused into the patient. Additionally, the new system can display which pumps have a current Guardrails® soft alert violation, to streamline alert reviews. Pharmacy Logistics is the first application released on the Alaris Infusion Viewer technology platform.

Full-Height CUBIE® Pocket: Available for both the Pyxis MedStation ES system and Pyxis MedStation 4000 system, the full-height CUBIE pocket leverages the same demonstrated best-practice benefits of half-height CUBIE pockets, but increases storage capacity for larger medications such as pre-filled syringes, vials and IV bags. This maximizes the availability of medications and reduces the time nurses spend gathering medication, while also increasing the security of high-risk and high-alert medications.

Rowa Vmax[1]: A robotic compact storage and dispensing system that is appropriate for a hospital’s central pharmacy as an efficient stock-management solution. The Rowa Vmax is a one-stop storage system that houses fast- and slow-moving medication, narcotics, temperature controlled items and other unique medication types. It uses barcode-based secure technology and dispenses medication within 8 to 12 seconds. The Rowa Vmax helps clinicians improve medication safety and streamline the administrative processes of the medication management. It can optimize a hospital’s medication inventory through transparent real-time data, which helps minimize the risk of dispensing errors, prevent stock outs and free-up time for patient care activities.

Interoperability Solutions: CareFusion has created a variety of interoperability solutions with other health IT systems to help streamline dispensing, administration and documentation of medication. The company will showcase how the Pyxis MedStation® system and Alaris devices share data with point of care technologies and electronic medical records to improve medication safety and workflow efficiency.

Source : http://www.news-medical.net/news/20121203/CareFusion-announces-new-products-to-help-improve-medication-safety.aspx

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Research report on global ophthalmic instrumentation industry

Research report on global ophthalmic instrumentation industry

Reportlinker.com announces that a new market research report is available in its catalogue: Global Ophthalmic Instrumentation Industry

This report analyzes the worldwide markets for Ophthalmic Instrumentation in Thousands of Units and US$ Million by the following Product Segments: Diagnostic Devices (Perimeters, Refractors, Slit Lamps, Tonometers, Fundus Cameras, Lens Meters, Ophthalmoscopes, Diagnostic Ultrasound Equipment, Corneal Topography Systems, & Diagnostic Imaging Systems), and Surgical Products (Ophthalmic Disposables, Ophthalmic Lasers, & Ophthalmic Surgical Microscope). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, The Middle East, and Latin America. Annual estimates and forecasts are provided for the period 2010 through 2018. A six-year historic analysis is also provided for these markets. The report profiles 128 companies including many key and niche players such as Abbott Medical Optics, Inc., Alcon, Inc., Bausch & Lomb, Inc., Carl Zeiss Meditec AG, Ellex Medical Lasers Limited, Iridex Corp., Lumenis Ltd., Nidek Co. Ltd., Topcon Corporation, and Topcon Medical Systems, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-2Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3Diagnostic Devices I-4Perimeters I-4Refractors I-4Slit Lamps I-4Tonometers I-4Fundus Cameras I-4Ophthalmoscopes I-4Diagnostic Ultrasound Equipment I-4Corneal Topography Systems I-5Diagnostic Imaging Systems I-5Surgical Products I-5Ophthalmic Lasers I-5Ophthalmic Surgical Microscopes I-5Ophthalmic Disposables I-5II. EXECUTIVE SUMMARY

1. GLOBAL MARKET OVERVIEW AND ANALYSIS II-1

Eyeing the Ophthalmic Potential II-1

Factors Underpinning Demand for Ophthalmic Instrumentation II-2

Ophthalmic Fact File II-2

Where the Growth Lies II-2

Demographics Spell Opportunities II-3

Table 1: Worldwide Distribution of Population by Country/

Region: 2011 (includes corresponding Graph/Chart) II-3

Table 2: Worldwide Distribution of 65+ Population by

Region/Country: 2011 (includes corresponding Graph/Chart) II-4

Table 3: Percentage Share of Global Population by Age Group,Worldwide: 2025 (includes corresponding Graph/Chart) II-4Market Dynamics II-4Cataract Surgical Market: Providing Lucrative Opportunities II-4A Statistical Review II-5Table 4: World Market for Cataract Procedures (2004-2010)(in Million) (includes corresponding Graph/Chart) II-5

Table 5: Global Cataract Market by Region (2011) -

Percentage Shares of Procedures for United States, Europe,

Asia Pacific, and Rest of the World (includes corresponding

Graph/Chart) II-5

Table 6: Cataract Market Worldwide by Product Segment (2011) -Percentage Share Breakdown of Revenues for IntraocularLenses (IOLs), Viscoelastics, Equipment, Instruments andOthers (includes corresponding Graph/Chart) II-6Table 7: Distribution of Ophthalmic Devices by TreatmentModality (includes corresponding Graph/Chart) II-6Diagnostics Ride the Sophistication Wave II-6Fundus Cameras II-6Evolving Technologies in Corneal Topography II-7Viewing Beyond the Conventional Visual Boundaries II-7Latest Surgical Tools to Propel Ophthalmic Equipment Sector II-8Integration of Ophthalmology and Material Science II-9Competition II-9Table 8: Leading Players in the Global Ophthalmic DiagnosticInstrument Market (2012): Percentage Share Breakdown ofRevenues for Topcon Corp., Carl Zeiss AG, and Others(includes corresponding Graph/Chart) II-9Worldwide Ophthalmic Diagnostic Market: Market Presence ofSelect Market Participants II-10

2. PRODUCT OVERVIEW II-11

Introduction II-11

Ophthalmology and Instrumentation II-11

Human Eye Analysis – A Valuable Health Indicator II-11

Types of Ophthalmic Instruments II-11

A. Ophthalmic Diagnostic Systems II-12

Ophthalmic Diagnostics Goes High Tech II-12

The Constituents II-12

Procedures for Measuring Eye Defects II-12

Perimeters II-13

Refractometer II-13

Slit Lamps II-13

Tonometers II-13

Fundus Cameras and Fundus Reflectometers II-14

Ocular Fundus Reflectometry II-14

Types of Ocular Fundus Reflectometry II-15

Lens Meters II-15

Ophthalmoscopes II-16

Ultrasound Equipment II-16

Corneal Topography Systems II-16

Use of Corneal Topography in Data Measurement and

Presentation II-16

Method of Studying Topographic Displays II-16

Use of Topography in Refractive Surgery II-17

B. Ophthalmic Surgical Products II-18

Ophthalmic Disposables II-18

Ophthalmic Lasers II-18

Role of Lasers in Medical and Ophthalmic Fields II-18

Origin and Development of Laser Surgery Techniques II-19

Types of Lasers II-19

Therapeutic Ophthalmic Lasers II-20

Argon Laser II-21

Q-switched Nd-YAG Laser II-21

Krypton Laser II-22

CO2 Laser II-22

Diode Laser II-22

Erbium Lasers II-22

Excimer Laser II-22

Excimer Lasers Available in the Market II-23

Frequency-Doubled, Tripled, Quadrupled Lasers II-23

Laser Sources for Surgical Effect II-24

Laser-Tissue Interactions II-24

Laser Photodisruption II-24

Laser Photocoagulation II-24

Role of Iris Color II-25

Disadvantages of Using Laser Scalpel II-25

Laser Phaco II-26

Ophthalmic Surgical Microscopes II-26

Other Ophthalmic Devices II-26

Keratometers II-26

Phaco Splitter II-27

Scalpel II-27

Ophthalmodynamometer II-27

Ophthalmodiaphanoscope II-27

3. OPHTHALMIC SURGERY MARKET – TECHNOLOGIES AND TRENDS II-28Table 9: Global Ophthalmic Surgery Market Breakdown by SurgeryProcedure (includes correspondingGraph/Chart) II-28A. Cataract Surgery II-28B. Refractive Surgery II-28Types of Refractive Surgery Procedures II-29Laser Vision Correction – A Broader Insight II-29Photorefractive Keratectomy (PRK) II-30Bottlenecks in PRK Procedure II-31Radial Keratotomy (RK) II-31Laser in-situ Keratomileusis (LASIK) II-32LASIK Vs. PRK II-32Custom LASIK – A New Milestone II-32Advantages of Custom LASIK technology II-33Wavefront: A Revolutionary Technology for Irregular Astigmatism II-33Manufacturers Offering Wavefront Technology II-34Femtosecond Laser – A New Innovation II-34Other Alternative Refractive Procedures II-34LASEK (Laser Epithelial Keratomileusis) II-34PAI (Photoablative Inlay) II-35Phototherapeutic Keratectomy (PTK) II-35Intrastromal Corneal Ring (Intacs) II-35Phakic Intraocular Lenses II-35

4. AN INSIGHT INTO EYES & EYE DISEASES II-36

Human Eyes – The Most Precious Possession II-36

Anatomy of Human Eye II-36

Process of Vision II-36

Effect of Sun Rays II-36

A Review of Various Eye Diseases II-37

A. Corneal Diseases II-37

Table 10: Leading Causes of Blindness Worldwide (includes

corresponding Graph/Chart) II-37

Macular Degeneration II-37

Cataract II-38

Types of Cataracts and their Common Causes II-38

Cataract Removal Techniques II-38

Phacoemulsification II-39

Glaucoma II-39

Surgical Treatment of Glaucoma II-39

Angiogenesis II-39

Astigmatism II-40

Presbyopia II-40

B. Ocular Defects Related to Nutritional Disorders II-40

Xerophthalmia, Caused by Vitamin A Deficiency II-40

Deficiency of Thiamine Leads to Amblyopia II-40

Retinal Anemia and Optic Atrophy Due to Vitamin B-12

Deficiency II-40

Vitamin C Deficiency Leads to Eye Related Hemorrhages II-40

C. Common Eye Related Problems Among Diabetics II-40

Blurred Vision II-41

Cataract in Diabetics (Differing from Normal Cataract) II-41

Macular Edema II-41

Mucormycosis II-41

Diplopia II-41

Gout II-42

Wilson’s Disease II-42

Hyperlipoproteinemias II-42

Ocular Albinism II-42

Keratoconus II-43

5. PRODUCT INTRODUCTIONS/INNOVATIONS II-44Carl Zeiss Meditec Introduces FORUM® 3.0 Data Management System II-44NIDEK Introduces CV-9000 II-44Bausch & Lomb and TPV Launch VICTUS™ Femtosecond LaserPlatform in the EU II-44Bausch & Lomb Launches enVista™ II-45Ellex to Introduce Integre Pro™ II-45Ellex to Introduce Diagnostic Ultrasound Mode for Eye Cubed™ II-45Lumenis Introduces Vision One™ II-45Topcon to Unveil New Range of Products II-46Ellex Introduces Integre Yellow™ Laser Photocoagulator II-46Keeler Introduces Applanation Tonometer II-47Bausch & Lomb to Launch Crystalens® AO Lens II-47Bausch + Lomb Storz® Ophthalmic Instruments Unveils NewDisposable Cataract Surgery Instruments II-47Bausch + Lomb Storz® Ophthalmic Instruments Unveils Tru-Size™Diamond Knife II-48Bausch & Lomb Launches the Stellaris® PC Vision EnhancementSystem for Use in Retinal Surgery II-48IRIDEX Launches New Line of Vitreoretinal Instruments II-48Nidek Launches New Varieties of Auto Lensmeters II-48Topcon Launches MS-SIO1 MicroSlit Illuminator in South America II-49

6. PRODUCT INNOVATIONS/LAUNCHES IN RECENT PAST – A PERSPECTIVE

BUILDER II-50

Paradigm Medical Introduces Surveyor 500 and Paravue 300 at AAO II-50

Reichert Launches New Tonometer II-50

Carl Zeiss Introduces Software Advancements for ATLAS® Corneal

Topography System II-50

Lumenis Unveils Cutting-Edge Ophthalmic Laser Delivery Technology II-51

Carl Zeiss Meditec Releases New Suite of Ophthalmic Solutions II-52

Ellex to Launch Advanced Ultrasound Systems and Ophthalmic Laser II-52

OIS Announces the Launch of Two New Products II-53

Topcon Unveils Advanced Corneal Analyzer II-54

Paradigm Medical Industries to Launch Ophthalmic Diagnostic

Devices II-54

Endure Introduces New Ophthalmic Surgical Microscope II-55

BD Medical – Ophthalmic Systems Launches New Knives to Treat

Astigmatism II-55

Topcon Launches Innovative SL-3G Slit Lamp II-55

Keeler Launches New Wireless Digital Indirect Ophthalmoscope II-56

Carl Zeiss Meditec Unveils Latest Ophthalmic Innovations Suite II-56

AMO Obtains U.S. FDA Clearance for Healon D® Viscoelastic II-57

Moria Launches New ‘One’ Line of One-Use Cataract Devices II-58

Kowa Optimed Launches New VK Digital Slit Lamp Imaging System II-58

Topcon Unveils TRC-NW8 Retinal Camera II-58

Topcon Launches 4-in-1 TRK-1P II-59

Topcon Unveils DC-3 Digital Camera II-59

Topcon Launches OMS-710 Surgical Microscope II-59

Carl Zeiss Meditec Rolls Out Humphrey Field Analyzer II-i II-59

Carl Zeiss Launches VisuMax® laser system II-60

Zecotek Photonics Introduces SL 1.4 Fiber Coupled Laser II-60

DRE Rolls Out Om2100 Ophthalmic Microscope II-60

Carl Zeiss Unveils i-Scription® Solution II-60

7. RECENT INDUSTRY ACTIVITY II-61Optomed Secures Japanese Ninsho Medical Device Certificationfor Optomed M5 Handheld Retinal Camera II-61Bioptigen Secures FDA Clearance to Market Envisu SpectralDomain Ophthalmic Imaging System in US II-61OptiMedica Installs Catalys Precision Laser System at MultipleClinics in Japan II-61Carl Zeiss Meditec Plans to Commence Clinical Trials of theReLEx® Smile Technique II-62Cutera Takes Over Aesthetic Business of IRIDEX II-62IRIDEX Declares Clinical Study Results of IRIDEX MicroPulse™Laser Therapy II-62US FDA Clears OptiMedica’s Catalys™ Precision Laser System II-63IRIDEX and Alcon Ink License and Distribution Agreement II-63Lumenis, Optovue and Kowa-Optimed Form Alliance in the US II-63Lumenis and Dual Laser Ink Business Cooperation and ProductDistribution Agreement II-64OPKO Health Divests Ophthalmic Instrumentation Business to Optos II-64Competitive Technologies and BiCOM Ink Strategic MarketingAgreement II-64Diagnos Inks Agreement with IRIS for CARA Commercialization II-64Heidelberg Establishes New Subsidiary Unit II-65Diagnos and Leahander Trading Ink New CARA Distribution Agreement II-65Canon Secures FDA Clearance for TX-20 Full Auto Tonometer II-65Diagnos Receives FDA Clearance for Cara Technology II-65Kowa Optimed to Establish Subsidiary in the UK II-66Technolas Perfect Vision Secures CE Mark Approval forSUPRACOR™ Presbyopia Laser Treatment II-66DuPage Medical Group Selects Merge Eye Care Suite and MergeiConnect Access II-66Novartis Takes Over Majority Stake in Alcon II-66Topcon Relocates Headquarters II-67Ellex and CenterVue Ink Distribution Agreement II-67Nidek Establishes NIDEK EYECARE DO BRASIL COMERCIO DEINSTRUMENTOS OPTICOS LTDA II-68Nidek Establishes Representative Office in Shanghai II-68Eyefinity®/OfficeMate® Enters into Partnership with Nidek II-68Keeler and Topcon Sign Distribution Agreement II-68Diagnos and Medical Technology Service Providers SignPartnership Agreement II-69

8. CORPORATE ACTIVITY IN RECENT PAST – A PERSPECTIVE BUILDER II-70

Alcon Takes Over Israeli Company Optonol II-70

Ophthalmic Imaging Wins FDA Approval for OIS EyeScan II-70

Kowa Optimed Receives FDA Approval for 3 Ophthalmic Imaging

Devices II-70

Reichert Acquires Foresee PHP® from Notal Vision II-71

DIAGNOS Agrees to Launch Pilot Project with CZC II-71

Abbott to Acquire Visiogen II-72

Premier Healthcare Inks Contracts with New Suppliers II-72

Cortec Group Acquires Katena Products II-72

BiB Signs Distribution Deal with Talia II-72

Paradigm Medical and CSO Sign Global Distribution Deal II-73

Abbott Takes Over Advanced Medical Optics II-73

OPKO Secures FDA Approval for New Combination Imaging System II-73

Paradigm Medical to Market LACE’s New Glaucoma Diagnostic Device II-74

AMO Obtains FDA Approval for its Advanced Femtosecond Laser II-74

OptiMedica Signs Deal with Topcon for Distributing PASCAL II-75

Essilor Expands Operations in Eastern Europe II-75

Bausch & Lomb Acquires eyeonics II-75

Advanced Medical Optics and Bausch & Lomb Ink Patent Agreement II-75

STAAR Surgical Acquires Stake in Canon Staar II-76

Ellex Medical Lasers Completes the Acquisition of Innovative

Imaging II-76

OccuLogix Acquires Stake in OcuSense II-76

OPKO Health Acquires Ophthalmic Technologies II-76

Affiliates of Warburg Pincus Complete the Acquisition of

Bausch & Lomb II-77

Reichert Acquires Pachymeter Products from Portable Ophthalmic

Devices II-77

OccuLogix Completes SOLX Acquisition II-77

Carl Zeiss Acquires Acri.Tec II-77

Volk Optical Signs two Distribution Agreements with Synergetics II-77

Nidek Commences a New Plant in Italy II-78

OptiMedica Enters into a Distribution Agreement with Topcon

Europe Medical II-78

Topcon Obtains FDA Approval for its 3D OCT-1000 II-78

Essilor of America Takes Over Majority Interest in OOGP II-78

Froptix, Acuity and eXegenics Merge to Form Opko Corporation II-78

NIDEK Obtains FDA Approval for ORION Auto-Retinal Imaging Device II-79

Ellex Obtains FDA Approval for Marketing 30XL Laser Slit Lamp II-79

Optos Enters into an Agreement with Pearl Vision II-79

IRIDEX and Synergetics Settle All Litigations II-79

Ellex Forays into Chinese Ophthalmic Laser Market II-80

Advanced Medical Optics Acquires IntraLase II-80

Advanced Medical Optics Takes Over WaveFront Sciences II-80

Bausch & Lomb Invests in AcuFocus II-81

Gebauer Establishes Subsidiary in the US II-81

9. FOCUS ON SELECT GLOBAL PLAYERS II-82Abbott Medical Optics, Inc. (US) II-82Alcon, Inc. (Corporate Headquarters – Switzerland) II-82Bausch & Lomb, Inc. (US) II-83Carl Zeiss Meditec AG (Germany) II-83Ellex Medical Lasers Limited (Australia) II-84Iridex Corp. (US) II-84Lumenis Ltd. (Israel) II-85Nidek Co. Ltd. (Japan) II-85Topcon Corp. (Japan) II-86Topcon Medical Systems, Inc. (US) II-86

10. GLOBAL MARKET PERSPECTIVE II-87

I. Unit Analytics II-87

Table 11: World Recent Past, Current & Future Analysis for

Ophthalmic Instrumentation by Geographic Region – US, Canada,

Japan, Europe, Asia-Pacific, the Middle East, and Latin

America Markets Independently Analyzed with Annual Sales

Figures in Units for Years 2010 through 2018 (includes

corresponding Graph/Chart) II-87

Table 12: World Historic Review for OphthalmicInstrumentation by Geographic Region – US, Canada, Japan,Europe, Asia-Pacific, the Middle East, and Latin AmericaMarkets Independently Analyzed with Annual Sales Figures inUnits for Years 2004 through 2009 (includes correspondingGraph/Chart) II-88

Table 13: World 15-Year Perspective for Ophthalmic

Instrumentation by Geographic Region – Percentage Breakdown

of Volume Sales for US, Canada, Japan, Europe, Asia-Pacific,

the Middle East, and Latin America Markets for Years 2004,

2011 & 2018 (includes corresponding Graph/Chart) II-89

Ophthalmic Instrumentation Market by Product Group/Segment II-90

Table 14: World Recent Past, Current & Future Analysis for

Ophthalmic Instrumentation by Product Group – Ophthalmic

Diagnostic Devices and Ophthalmic Surgical Products Markets

Independently Analyzed with Annual Sales Figures in Units for

Years 2010 through 2018 (includes corresponding Graph/Chart) II-90

Table 15: World Historic Review for OphthalmicInstrumentation by Product Group – Ophthalmic DiagnosticDevices and Ophthalmic Surgical Products MarketsIndependently Analyzed with Annual Sales Figures in Units forYears 2004 through 2009 (includes corresponding Graph/Chart) II-91

Table 16: World 15-Year Perspective for Ophthalmic

Instrumentation by Product Group – Percentage Breakdown of

Volume Sales for Ophthalmic Diagnostic Devices and Ophthalmic

Surgical Products Markets for Years 2004, 2011 & 2018

(includes corresponding Graph/Chart) II-92

Ophthalmic Diagnostic Devices II-93

Table 17: World Recent Past, Current & Future Analysis for

Ophthalmic Diagnostic Devices by Geographic Region – US,

Canada, Japan, Europe, Asia-Pacific, the Middle East, and

Latin America Markets Independently Analyzed with Annual

Sales Figures in Units for Years 2010 through 2018 (includes

corresponding Graph/Chart) II-93

Table 18: World Historic Review for Ophthalmic DiagnosticDevices by Geographic Region – US, Canada, Japan, Europe,Asia-Pacific, the Middle East, and Latin America MarketsIndependently Analyzed with Annual Sales Figures in Units forYears 2004 through 2009 (includes corresponding Graph/Chart) II-94

Table 19: World 15-Year Perspective for Ophthalmic Diagnostic

Devices by Geographic Region – Percentage Breakdown of Volume

Sales for US, Canada, Japan, Europe, Asia-Pacific, the Middle

East, and Latin America Markets for Years 2004, 2011 & 2018

(includes corresponding Graph/Chart) II-95

Table 20: World Recent Past, Current & Future Analysis forOphthalmic Diagnostic Devices by Product Segment -Ophthalmoscopes, Lens Meters, Slit Lamps, Tonometers,Perimeters, Corneal Topography Systems, Refractors,Diagnostic Imaging Systems, Fundus Cameras, and DiagnosticUltrasound Equipment Markets Independently Analyzed withAnnual Sales Figures in Units for Years 2010 through 2018(includes corresponding Graph/Chart) II-96

Table 21: World Historic Review for Ophthalmic Diagnostic

Devices by Product Segment – Ophthalmoscopes, Lens Meters,

Slit Lamps, Tonometers, Perimeters, Corneal Topography

Systems, Refractors, Diagnostic Imaging Systems, Fundus

Cameras, and Diagnostic Ultrasound Equipment Markets

Independently Analyzed with Annual Sales Figures in Units for

Years 2004 through 2009 (includes corresponding Graph/Chart) II-97

Table 22: World 15-Year Perspective for Ophthalmic DiagnosticDevices by Product Segment – Percentage Breakdown of VolumeSales for Ophthalmoscopes, Lens Meters, Slit Lamps,Tonometers, Perimeters, Corneal Topography Systems,Refractors, Diagnostic Imaging Systems, Fundus Cameras, andDiagnostic Ultrasound Equipment Markets for Years 2004, 2011& 2018 (includes corresponding Graph/Chart) II-98Ophthalmic Surgical Products II-99Table 23: World Recent Past, Current & Future Analysis forOphthalmic Surgical Devices by Geographic Region – US,Canada, Japan, Europe, Asia-Pacific, the Middle East, andLatin America Markets Independently Analyzed with AnnualSales Figures in Units for Years 2010 through 2018 (includescorresponding Graph/Chart) II-99

Table 24: World Historic Review for Ophthalmic Surgical

Devices by Geographic Region – US, Canada, Japan, Europe,

Asia-Pacific, the Middle East, and Latin America Markets

Independently Analyzed with Annual Sales Figures in Units for

Years 2004 through 2009 (includes corresponding Graph/Chart) II-100

Table 25: World 15-Year Perspective for Ophthalmic SurgicalDevices by Geographic Region – Percentage Breakdown of VolumeSales for US, Canada, Japan, Europe, Asia-Pacific, the MiddleEast, and Latin America Markets for Years 2004, 2011 & 2018(includes corresponding Graph/Chart) II-101Ophthalmic Surgical Devices by Product Segment II-102Table 26: World Recent Past, Current & Future Analysis forOphthalmic Surgical Devices by Product Segment – OphthalmicLasers and Ophthalmic Surgical Microscopes MarketsIndependently Analyzed with Annual Sales Figures in Units forYears 2010 through 2018 (includes corresponding Graph/Chart) II-102

Table 27: World Historic Review for Ophthalmic Surgical

Devices by Product Segment – Ophthalmic Lasers and Ophthalmic

Surgical Microscopes Markets Independently Analyzed with

Annual Sales Figures in Units for Years 2004 through 2009

(includes corresponding Graph/Chart) II-103

Table 28: World 15-Year Perspective for Ophthalmic SurgicalDevices by Product Segment – Percentage Breakdown of VolumeSales for Ophthalmic Lasers and Ophthalmic SurgicalMicroscopes Markets for Years 2004, 2011 & 2018 (includescorresponding Graph/Chart) II-104II. Value Analytics II-105Table 29: World Recent Past, Current & Future Analysis forOphthalmic Instrumentation by Geographic Region – US, Canada,Japan, Europe, Asia-Pacific, the Middle East, and LatinAmerica Markets Independently Analyzed with Annual SalesFigures in US$ Thousands for Years 2010 through 2018(includes corresponding Graph/Chart) II-105

Table 30: World Historic Review for Ophthalmic

Instrumentation by Geographic Region – US, Canada, Japan,

Europe, Asia-Pacific, the Middle East, and Latin America

Markets Independently Analyzed with Annual Sales Figures in

US$ Thousands for Years 2000 through 2006 (includes

corresponding Graph/Chart) II-106

Table 31: World 15-Year Perspective for OphthalmicInstrumentation by Geographic Region – Percentage Breakdownof Value Sales for US, Canada, Japan, Europe, Asia-Pacific,the Middle East, and Latin America Markets for Years 2004,2011 & 2018 (includes corresponding Graph/Chart) II-107Analytics by Segment II-108Table 32: World Recent Past, Current & Future Analysis forOphthalmic Instrumentation by Product Segment – OphthalmicDiagnostic Devices and Ophthalmic Surgical Devices MarketsIndependently Analyzed with Annual Sales Figures in US$Thousands for Years 2010 through 2018 (includes correspondingGraph/Chart) II-108

Table 33: World Historic Review for Ophthalmic

Instrumentation by Product Segment – Ophthalmic Diagnostic

Devices and Ophthalmic Surgical Devices Markets Independently

Analyzed with Annual Sales Figures in US$ Thousands for Years

2004 through 2009 corresponding Graph/Chart) II-109

Table 34: World 15-Year Perspective for OphthalmicInstrumentation by Product Segment- Percentage Breakdown ofValue Sales for Ophthalmic Diagnostic Devices and OphthalmicSurgical Devices Markets for Years 2004, 2011 & 2018(includes corresponding Graph/Chart) II-110Ophthalmic Diagnostic Devices II-111Table 35: World Recent Past, Current & Future Analysis forOphthalmic Diagnostic Devices by Geographic Region – US,Canada, Japan, Europe, Asia-Pacific, the Middle East, andLatin America Markets Independently Analyzed with AnnualSales Figures in US$ Thousands for Years 2010 through 2018(includes corresponding Graph/Chart) II-111

Table 36: World Historic Review for Ophthalmic Diagnostic

Devices by Geographic Region – US, Canada, Japan, Europe,

Asia-Pacific, the Middle East, and Latin America Markets

Independently Analyzed with Annual Sales Figures in US$

Thousands for Years 2004 through 2009 (includes corresponding

Graph/Chart) II-112

Table 37: World 15-Year Perspective for Ophthalmic DiagnosticDevices by Geographic Region – Percentage Breakdown of ValueSales for US, Canada, Japan, Europe, Asia-Pacific, the MiddleEast, and Latin America Markets for Years 2004, 2011 & 2018(includes corresponding Graph/Chart) II-113Ophthalmic Diagnostic Devices by Segment II-114Table 38: World Recent Past, Current & Future Analysis forOphthalmic Diagnostic Devices by Product Segment – CornealTopography Systems, Lens Meters, Refractors, Ophthalmoscopes,Slit Lamps, Fundus Cameras, Perimeters, Diagnostic ImagingSystems, Tonometers, and Diagnostic Ultrasound EquipmentMarkets Independently Analyzed with Annual Sales Figures inUS$ Thousands for Years 2010 through 2018 (includescorresponding Graph/Chart) II-114

Table 39: World Historic Review for Ophthalmic Diagnostic

Devices by Product Segment – Corneal Topography Systems,

Refractors, Perimeters, Slit Lamps, Lens Meters,

Ophthalmoscopes, Fundus Cameras, Diagnostic Ultrasound

Equipment, Diagnostic Imaging Systems, and Tonometers Markets

Independently Analyzed with Annual Sales Figures in US$

Thousands for Years 2004 through 2009 (includes corresponding

Graph/Chart) II-115

Table 40: World 15-Year Perspective for Ophthalmic DiagnosticDevices by Product Segment – Percentage Breakdown of ValueSales for Corneal Topography Systems, Refractors, Perimeters,Slit Lamps, Diagnostic Ultrasound Equipment, Lens Meters,Fundus Cameras, Diagnostic Imaging Systems, Ophthalmoscopes,and Tonometers Markets for Years 2004, 2011 & 2018 (includescorresponding Graph/Chart) II-116Ophthalmic Surgical Devices II-117Table 41: World Recent Past, Current & Future Analysis forOphthalmic Surgical Devices by Geographic Region – US,Canada, Japan, Europe, Asia-Pacific, the Middle East, andLatin America Markets Independently Analyzed with AnnualSales Figures in US$ Thousands for Years 2010 through 2018(includes corresponding Graph/Chart) II-117

Table 42: World Historic Review for Ophthalmic Surgical

Devices by Geographic Region – US, Canada, Japan, Europe,

Asia-Pacific, the Middle East, and Latin America Markets

Independently Analyzed with Annual Sales Figures in US$

Thousands for Years 2004 through 2009 (includes corresponding

Graph/Chart) II-118

Table 43: World 15-Year Perspective for Ophthalmic SurgicalDevices by Geographic Region – Percentage Breakdown of ValueSales for US, Canada, Japan, Europe, Asia-Pacific, the MiddleEast, and Latin America Markets for Years 2004, 2011 & 2018(includes corresponding Graph/Chart) II-119Ophthalmic Surgical Devices By Segment II-120Table 44: World Recent Past, Current & Future Analysis forOphthalmic Surgical Devices by Product Segment – OphthalmicDisposables, Ophthalmic Lasers, and Ophthalmic SurgicalMicroscopes Markets Independently Analyzed with Annual SalesFigures in US$ Thousands for Years 2010 through 2018(includes corresponding Graph/Chart) II-120

Table 45: World Historic Review for Ophthalmic Surgical

Devices by Product Segment – Ophthalmic Disposables,

Ophthalmic Lasers, and Ophthalmic Surgical Microscopes

Markets Independently Analyzed with Annual Sales Figures in

US$ Thousands for Years 2004 through 2009 (includes

corresponding Graph/Chart) II-121

Table 46: World 15-Year Perspective for Ophthalmic SurgicalDevices by Product Segment – Percentage Breakdown of ValueSales for Ophthalmic Disposables, Ophthalmic Lasers, andOphthalmic Surgical Microscopes Markets for Years 2004, 2011& 2018 (includes corresponding Graph/Chart) II-122III. MARKET

1. THE UNITED STATES III-1

A.Market Analysis III-1

Outlook III-1

Growth Drivers III-1

Fact File III-2

Ophthalmic Marketers to Catch Up on Ageing ‘Baby Boomers’ III-2

Alternative Procedures to Offer Growth Prospects III-3

Femtolasers Open New Ground for Cataract Surgery III-3

Trade Statistics III-4

Exports III-4

Table 47: US Exports of Ophthalmic Instruments and

Appliances (2009 & 2010): Percentage Share Breakdown of

Export Value by Destination Country (includes

corresponding Graph/Chart) III-4

Imports III-5

Table 48: US Imports of Ophthalmic Instruments and

Appliances (2009 & 2010): Percentage Share Breakdown of

Import Value by Source Country (includes corresponding

Graph/Chart) III-5

Statistical Findings On Ophthalmic Diseases in the United

States III-5

Table 49: Prevalence of Age-Related Wet Macular

Degeneration in the United States for the Years 2006, 2009, &

2012 (In Millions of Individuals) (includes corresponding

Graph/Chart) III-5

Table 50: Number of Individuals Treated for Wet AMD in theUnited States (In Thousands) for the Years 2006, 2009 &2012 (includes corresponding Graph/Chart) III-6

Table 51: Prevalence of Ocular Hypertension (OHT) in the

United States for the Years 2006, 2009, & 2011 (In Millions

of Individuals) (includes corresponding Graph/Chart) III-6

Table 52: Prevalence of Primary Open Angle Glaucoma (POAG)in the United States for the Years 2006, 2009, & 2011 (InMillions of Individuals) (includes correspondingGraph/Chart) III-6

Table 53: Number of Individuals Treated for Glaucoma in the

United Sates (2006, 2009 and 2011): Breakdown by Type -

Ocular Hypertension (OHT), Primary Open Angle Glaucoma

(POAG), Normal Tension Glaucoma (NTG), Pigmentary Glaucoma

(PG) and Exfoliative Glaucoma (EG) (In 000 Individuals)

(includes corresponding Graph/Chart) III-7

Table 54: Prevalence of Cataract in the United States forthe Years 2006, 2009 & 2012 (In Millions of Individuals)(includes corresponding Graph/Chart) III-7Product Introductions/Developments III-8Strategic Corporate Developments III-10Key Players III-14B.Market Analytics III-17I. Unit Analytics III-17Table 55: The US Recent Past, Current & Future Analysis forOphthalmic Instrumentation by Product Group/Segment -Diagnostic Devices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical ProductsMarkets Independently Analyzed with Annual Sales Figures inUnits for Years 2010 through 2018 (includes correspondingGraph/Chart) III-17

Table 56: The US Historic Review for Ophthalmic

Instrumentation by Product Group/Segment – Diagnostic

Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

Markets Independently Analyzed with Annual Sales Figures in

Units for Years 2004 through 2009 (includes corresponding

Graph/Chart) III-18

Table 57: The US 15-Year Perspective for OphthalmicInstrumentation by Product Group/Segment – PercentageBreakdown of Volume Sales for Diagnostic Devices (CornealTopography Systems, Refractors, Perimeters, Slit Lamps,Diagnostic Ultrasound Equipment, Lens Meters, FundusCameras, Diagnostic Imaging Systems, Ophthalmoscopes, andTonometers) and Surgical Products Markets for 2004, 2011 &2018 (includes corresponding Graph/Chart) III-19II. Value Analytics III-20Table 58: The US Recent Past, Current & Future Analysis forOphthalmic Instrumentation by Product Group/Segment -Diagnostic Devices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical Products(Ophthalmic Disposables, Ophthalmic Lasers, and OphthalmicSurgical Microscope) Markets Independently Analyzed withAnnual Sales Figures in US$ Thousands for Years 2010through 2018 (includes corresponding Graph/Chart) III-20

Table 59: The US Historic Review for Ophthalmic

Instrumentation by Product Group/Segment – Diagnostic

Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

(Ophthalmic Disposables, Ophthalmic Lasers, and Ophthalmic

Surgical Microscope) Markets Independently Analyzed with

Annual Sales Figures in US$ Thousands for Years 2004

through 2009 (includes corresponding Graph/Chart) III-21

Table 60: The US 15-Year Perspective for OphthalmicInstrumentation by Product Group/Segment – PercentageBreakdown of Value Sales for Diagnostic Devices (CornealTopography Systems, Refractors, Perimeters, Slit Lamps,Diagnostic Ultrasound Equipment, Lens Meters, FundusCameras, Diagnostic Imaging Systems, Ophthalmoscopes, andTonometers) and Surgical Products (Ophthalmic Disposables,Ophthalmic Lasers, and Ophthalmic Surgical Microscope)Markets for 2004, 2011 & 2018 (includes correspondingGraph/Chart) III-22

2. CANADA III-23

A.Market Analysis III-23

Outlook III-23

Trade Statistics III-23

Exports III-23

Table 61: Canadian Exports of Ophthalmic Instruments and

Appliances (2009 & 2010): Percentage Share Breakdown of

Export Value by Destination Country (includes

corresponding Graph/Chart) III-23

Imports III-24

Table 62: Canadian Imports of Ophthalmic Instruments and

Appliances (2009 & 2010): Percentage Share Breakdown of

Import Value by Source Country (includes corresponding

Graph/Chart) III-24

B.Market Analytics III-25

I. Unit Analytics III-25

Table 63: Canadian Recent Past, Current & Future Analysis

for Ophthalmic Instrumentation by Product Group/Segment -

Diagnostic Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

Markets Independently Analyzed with Annual Sales Figures in

Units for Years 2010 through 2018 (includes corresponding

Graph/Chart) III-25

Table 64: Canadian Historic Review for OphthalmicInstrumentation by Product Group/Segment – DiagnosticDevices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical ProductsMarkets Independently Analyzed with Annual Sales Figures inUnits for Years 2004 through 2009 (includes correspondingGraph/Chart) III-26

Table 65: Canadian 15-Year Perspective for Ophthalmic

Instrumentation by Product Group/Segment – Percentage

Breakdown of Volume Sales for Diagnostic Devices (Corneal

Topography Systems, Refractors, Perimeters, Slit Lamps,

Diagnostic Ultrasound Equipment, Lens Meters, Fundus

Cameras, Diagnostic Imaging Systems, Ophthalmoscopes, and

Tonometers) and Surgical Products Markets for 2004, 2011 &

2018 (includes corresponding Graph/Chart) III-27

II. Value Analytics III-28

Table 66: Canadian Recent Past, Current & Future Analysis

for Ophthalmic Instrumentation by Product Group/Segment -

Diagnostic Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

(Ophthalmic Disposables, Ophthalmic Lasers, and Ophthalmic

Surgical Microscope) Markets Independently Analyzed with

Annual Sales Figures in US$ Thousands for Years 2010

through 2018 (includes corresponding Graph/Chart) III-28

Table 67: Canadian Historic Review for OphthalmicInstrumentation by Product Group/Segment – DiagnosticDevices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical Products(Ophthalmic Disposables, Ophthalmic Lasers, and OphthalmicSurgical Microscope) Markets Independently Analyzed withAnnual Sales Figures in US$ Thousands for Years 2004through 2009 (includes corresponding Graph/Chart) III-29

Table 68: Canadian 15-Year Perspective for Ophthalmic

Instrumentation by Product Group/Segment – Percentage

Breakdown of Value Sales for Diagnostic Devices (Corneal

Topography Systems, Refractors, Perimeters, Slit Lamps,

Diagnostic Ultrasound Equipment, Lens Meters, Fundus

Cameras, Diagnostic Imaging Systems, Ophthalmoscopes, and

Tonometers) and Surgical Products (Ophthalmic Disposables,

Ophthalmic Lasers, and Ophthalmic Surgical Microscope)

Markets for Years 2004, 2011 & 2018 (includes corresponding

Graph/Chart) III-30

3. JAPAN III-31A.Market Analysis III-31Strategic Corporate Developments III-31Select Players III-33B.Market Analytics III-35I. Unit Analytics III-35Table 69: Japanese Recent Past, Current & Future Analysisfor Ophthalmic Instrumentation by Product Group/Segment -Diagnostic Devices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical ProductsMarkets Independently Analyzed with Annual Sales Figures inUnits for Years 2010 through 2018 (includes correspondingGraph/Chart) III-35

Table 70: Japanese Historic Review for Ophthalmic

Instrumentation by Product Group/Segment – Diagnostic

Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

Markets Independently Analyzed with Annual Sales Figures in

Units for Years 2004 through 2009 (includes corresponding

Graph/Chart) III-36

Table 71: Japanese 15-Year Perspective for OphthalmicInstrumentation by Product Group/Segment – PercentageBreakdown of Volume Sales for Diagnostic Devices (CornealTopography Systems, Refractors, Perimeters, Slit Lamps,Diagnostic Ultrasound Equipment, Lens Meters, FundusCameras, Diagnostic Imaging Systems, Ophthalmoscopes, andTonometers) and Surgical Products Markets for 2004, 2011 &2018 (includes corresponding Graph/Chart) III-37II. Value Analytics III-38Table 72: Japanese Recent Past, Current & Future Analysisfor Ophthalmic Instrumentation by Product Group/Segment -Diagnostic Devices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical Products(Ophthalmic Disposables, Ophthalmic Lasers, and OphthalmicSurgical Microscope) Markets Independently Analyzed withAnnual Sales Figures in US$ Thousands for Years 2010through 2018 (includes corresponding Graph/Chart) III-38

Table 73: Japanese Historic Review for Ophthalmic

Instrumentation by Product Group/Segment – Diagnostic

Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

(Ophthalmic Disposables, Ophthalmic Lasers, and Ophthalmic

Surgical Microscope) Markets Independently Analyzed with

Annual Sales Figures in US$ Thousands for Years 2004

through 2009 (includes corresponding Graph/Chart) III-39

Table 74: Japanese 15-Year Perspective for OphthalmicInstrumentation by Product Group/Segment – PercentageBreakdown of Value Sales for Diagnostic Devices (CornealTopography Systems, Refractors, Perimeters, Slit Lamps,Diagnostic Ultrasound Equipment, Lens Meters, FundusCameras, Diagnostic Imaging Systems, Ophthalmoscopes, andTonometers) and Surgical Products (Ophthalmic Disposables,ophthalmic Lasers, and Ophthalmic Surgical Microscope)Markets for 2004, 2011 & 2018 (includes correspondingGraph/Chart) III-40

4. EUROPE III-41

A.Market Analysis III-41

Outlook III-41

Refractive Surgery Market III-41

Select Players III-41

Product launches/ developments III-43

Strategic corporate developments III-43

B.Market Analytics III-46

I. Unit Analytics III-46

Table 75: European Recent Past, Current & Future Analysis

for Ophthalmic Instrumentation by Geographic Region -

France, Germany, Italy, UK, Spain, Russia & Rest of Europe

Markets Independently Analyzed with Annual Sales Figures in

Units for Years 2010 through 2018 (includes corresponding

Graph/Chart) III-46

Table 76: European Historic Review for OphthalmicInstrumentation by Geographic Region – France, Germany,Italy, UK, Spain, Russia & Rest of Europe MarketsIndependently Analyzed with Annual Sales Figures in Unitsfor Years 2004 through 2009 (includes correspondingGraph/Chart) III-47

Table 77: European 15-Year Perspective for Ophthalmic

Instrumentation by Geographic Region – Percentage Breakdown

of Volume Sales for France, Germany, Italy, UK, Spain,

Russia & Rest of Europe Markets for Years 2004, 2011 & 2018

(includes corresponding Graph/Chart) III-48

Table 78: European Recent Past, Current & Future Analysisfor Ophthalmic Instrumentation by Product Group/Segment -Diagnostic Devices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical ProductsMarkets Independently Analyzed with Annual Sales Figures inUnits for Years 2010 through 2018 (includes correspondingGraph/Chart) III-49

Table 79: European Historic Review for Ophthalmic

Instrumentation by Product Group/Segment – Diagnostic

Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

Markets Independently Analyzed with Annual Sales Figures in

Units for Years 2004 through 2009 (includes corresponding

Graph/Chart) III-50

Table 80: European 15-Year Perspective for OphthalmicInstrumentation by Product Group/Segment – PercentageBreakdown of Volume Sales for Diagnostic Devices (CornealTopography Systems, Refractors, Perimeters, Slit Lamps,Diagnostic Ultrasound Equipment, Lens Meters, FundusCameras, Diagnostic Imaging Systems, Ophthalmoscopes, andTonometers) and Surgical Products Markets for 2004, 2011 &2018 (includes corresponding Graph/Chart) III-51II. Value Analytics III-52Table 81: European Recent Past, Current & Future Analysisfor Ophthalmic Instrumentation by Geographic Region -France, Germany, Italy, UK, Spain, Russia & Rest of EuropeMarkets Independently Analyzed with Annual Sales Figures inUS$ Thousands for Years 2010 through 2018 (includescorresponding Graph/Chart) III-52

Table 82: European Historic Review for Ophthalmic

Instrumentation by Geographic Region – France, Germany,

Italy, UK, Spain, Russia & Rest of Europe Markets

Independently Analyzed with Annual Sales Figures in US$

Thousands for Years 2004 through 2009 (includes

corresponding Graph/Chart) III-53

Table 83: European 15-Year Perspective for OphthalmicInstrumentation by Geographic Region – Percentage Breakdownof Value Sales for France, Germany, Italy, UK, Spain,Russia & Rest of Europe Markets for Years 2004, 2011 & 2018(includes corresponding Graph/Chart) III-54

Table 84: European Recent Past, Current & Future Analysis

for Ophthalmic Instrumentation by Product Group/Segment -

Diagnostic Devices (Corneal Topography Systems, Refractors,

Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,

Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,

Ophthalmoscopes, and Tonometers) and Surgical Products

(Ophthalmic Disposables, Ophthalmic Lasers, and Ophthalmic

Surgical Microscope) Markets Independently Analyzed with

Annual Sales Figures in US$ Thousands for Years 2010

through 2018 (includes corresponding Graph/Chart) III-55

Table 85: European Historic Review for OphthalmicInstrumentation by Product Group/Segment – DiagnosticDevices (Corneal Topography Systems, Refractors,Perimeters, Slit Lamps, Diagnostic Ultrasound Equipment,Lens Meters, Fundus Cameras, Diagnostic Imaging Systems,Ophthalmoscopes, and Tonometers) and Surgical Products(Ophthalmic Disposables, Ophthalmic Lasers, and OphthalmicSurgical Microscope) Markets Independently Analyzed withAnnual Sales Figures in US$ Thousands for Years 2004through 2009 (includes corresponding Graph/Chart) III-56

Source : http://www.news-medical.net/news/20121203/Research-report-on-global-ophthalmic-instrumentation-industry.aspx

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Algorithms improve certainty in ruling out deep and pelvic vein thrombosis at primary level of patient care

Algorithms improve certainty in ruling out deep and pelvic vein thrombosis at primary level of patient care

Algorithms improve certainty in ruling out deep and pelvic vein thrombosis at the primary level of patient care, say Lobna El Tabei and her co-authors in the current issue of the Deutsches Ärzteblatt International.

Deep vein thrombosis (DVT) can lead to fatal pulmonary embolism or chronic post-thrombotic syndrome. To improve differential diagnostic certainty, scores have been developed that allow the clinical probability of DVT to be calculated on the basis of weighted combinations of individual clinical findings. Items of these scores are, for example, cancer, paresis of the leg, extended periods of bed rest, swelling, and pain.

The primary aim of the study was to determine diagnostic accuracy regarding exclusion of DVT using a treatment algorithm consisting of one of these scores, the Wells score, followed by either a D-dimer test and/or compression sonography—depending on the result of the Wells score—and to compare this with the diagnostic accuracy of the primary care physician’s clinical judgment alone.

The algorithm investigated by the authors allows the primary care physician to rule out DVT with a high degree of probability. In this study, which included 395 patients, only 1% of cases of DVT were missed, compared with 5% when relying on clinical judgment alone.

Source : http://www.news-medical.net/news/20121127/Algorithms-improve-certainty-in-ruling-out-deep-and-pelvic-vein-thrombosis-at-primary-level-of-patient-care.aspx

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New Pills Send Messages When Swallowed

New Pills Send Messages When Swallowed

New Pills Send Messages When Swallowed

GAINESVILLE, Fla. — Call them tattletale pills.

Seeking a way to confirm that patients have taken their medication, University of Florida engineering researchers have added a tiny microchip and digestible antenna to a standard pill capsule. The prototype is intended to pave the way for mass-produced pills that, when ingested, automatically alert doctors, loved ones or scientists working with patients in clinical drug trials.

“It is a way to monitor whether your patient is taking their medication in a timely manner,” said Rizwan Bashirullah, UF assistant professor in electrical and computer engineering.

Such a pill is needed because many patients forget, refuse or bungle the job of taking their medication. This causes or exacerbates medical problems, spurs hospitalizations or expensive medical procedures and undercuts clinical trials of new drugs.

The American Heart Association calls patients’ failure to follow prescription regimens “the number one problem in treating illness today.” Studies have found, for example, that patients with chronic diseases normally take only about half their prescribed medications. According to the American Heart Association, 10 percent of hospital admissions result from patients not following the guidelines on their prescriptions. Other studies have found that not taking medication properly results in 218,000 deaths annually.

So-called “medication compliance” is a big problem for clinical trials, Bashirullah said, because failure to take experiment drugs skews studies’ results or renders them meaningless. As a result, researchers often require visual confirmation of participants taking pills, an extremely expensive proposition if hundreds or thousands of people are participating in the trials.

“The idea is to use technology to do this in a more seamless, much less expensive way,” Bashirullah said.

Bashirullah, doctoral student Hong Yu, UF materials science and engineering Professor Chris Batich and Neil Euliano of Gainesville-based Convergent Engineering designed and tested a system with two main parts.

One part is the pill, a standard white capsule coated with a label embossed with silvery lines. The lines comprise the antenna, which is printed using ink made of nontoxic, conductive silver nanoparticles. The pill also contains a tiny microchip, one about the size of a period.

When a patient takes the pill, it communicates with the second main element of the system: a small electronic device carried or worn by the patient – for now, a stand-alone device, but in the future perhaps built into a watch or cell phone. The device then signals a cell phone or laptop that the pill has been ingested, in turn informing doctors or family members.

Bashirullah said the pill needs no battery because the device sends it power via imperceptible bursts of extremely low-voltage electricity. The bursts energize the microchip to send signals relayed via the antenna. Eventually the patient’s stomach acid breaks down the antenna – the microchip is passed through the gastrointestinal tract — but not before the pill confirms its own ingestion.

“The vision of this project has always been that you have an antenna that is biocompatible, and that essentially dissolves a little while after entering the body,” Bashirullah said.

The team has successfully tested the pill system in artificial human models, as well as cadavers. Researchers have also simulated stomach acids to break down the antenna to learn what traces it leaves behind. Bashirullah said those tests had determined the amount of silver retained in the body is tiny, less than what people often receive from common tap water.

The researchers presented their findings at a conference in Japan last year and are currently at work on a scholarly paper about their research. They have applied for patents, and Bashirullah said a UF spinoff company is seeking to develop the next generation of the pill for FDA testing and commercial development. The research was funded by grants totaling about $700,000 from the National Science Foundation, Convergent Engineering and the Florida High Tech Corridor Council.

University of Florida researchers have developed a signaling technology that can be embedded into drug tablets to notify clinicians and caretakers that a pill has been ingested. Although a bit of electronics is going to be moving through the digestive system, the researchers believe that it will pass safely without causing side effects to the patient. If the technology proves itself, we may soon be using it to confirm compliance in clinical trials or to monitor patients under a strict drug regimen.

One part is the pill, a standard white capsule coated with a label embossed with silvery lines. The lines comprise the antenna, which is printed using ink made of nontoxic, conductive silver nanoparticles. The pill also contains a tiny microchip, one about the size of a period.

When a patient takes the pill, it communicates with the second main element of the system: a small electronic device carried or worn by the patient – for now, a stand-alone device, but in the future perhaps built into a watch or cell phone. The device then signals a cell phone or laptop that the pill has been ingested, in turn informing doctors or family members.

Bashirullah [Rizwan Bashirullah, UF assistant professor in electrical and computer engineering] said the pill needs no battery because the device sends it power via imperceptible bursts of extremely low-voltage electricity. The bursts energize the microchip to send signals relayed via the antenna. Eventually the patient’s stomach acid breaks down the antenna – the microchip is passed through the gastrointestinal tract — but not before the pill confirms its own ingestion.

The team has successfully tested the pill system in artificial human models, as well as cadavers. Researchers have also simulated stomach acids to break down the antenna to learn what traces it leaves behind. Bashirullah said those tests had determined the amount of silver retained in the body is tiny, less than what people often receive from common tap water.

source : http://news.ufl.edu/2010/03/31/antenna-pill-2/

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BSD-2000 Hyperthermia System purchased by Cancer Treatment Centers of America

BSD-2000 Hyperthermia System purchased by Cancer Treatment Centers of America

BSD Medical Corporation (NASDAQ: BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize targeted heat therapy to treat cancer, announced today that the Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (WRMC), located in Goodyear, Arizona, has purchased a BSD-2000 Hyperthermia System (BSD-2000). WRMC serves the Western United States, including the major metropolitan areas of Phoenix, Denver, Los Angeles, Las Vegas, Seattle, Portland and Albuquerque. This will be the eighth BSD Hyperthermia system purchased by CTCA®.

“offering the very best in cancer care.”

WRMC is a state-of-the-art, all-digital cancer hospital that provides advanced cancer treatments, world-class technologies and integrative therapies under one roof. The 213,000-square-foot facility is located on a 25-acre site, which is part of the Phoenix metropolitan area. Like the other CTCA cancer hospitals, WRMC provides the most advanced therapeutic resources in cancer treatment (http://www.cancercenter.com/western-hospital/about-western/history.cfm).

CTCA is a network of hospitals and one of the premier providers of cancer care in the world. CTCA physicians specialize in treating many types of cancer, including complex and advanced stage cases. CTCA is committed to revolutionizing cancer care by providing the most advanced and effective cancer treatments and integrative therapies available in order to treat the cancer and improve the patient’s treatment experience and quality of life. The CTCA hospitals were recently recognized by the Commission on Cancer of the American College of Surgeons as “offering the very best in cancer care.”

Source : http://www.news-medical.net/news/20121126/BSD-2000-Hyperthermia-System-purchased-by-Cancer-Treatment-Centers-of-America.aspx

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The Proton Beam Arms Race

The Proton Beam Arms Race

The Proton Beam Arms Race

Dear CMS: Stop the proton beam arms race

If Medicare payments for proton beam therapy are what is driving the construction of too many such machines, why doesn’t Medicare change the reimbursement? That’s my simple question for the day.

What prompts it is this story from the Midwest, where University Hospital has entered the proton beam machine arms race with plans to spend $30 million. Here’s the story from MedCity News.

Excerpts:

Few argue that proton therapy is ineffective, though many would like to see it subjected to rigorous testing. The National Cancer Institute (NCI) in 2009 expressed concern that “enthusiasm for this promising therapy may be getting ahead of the research.” NCI experts worry about a lack of published randomized, controlled trials that show proton therapy works better than standard radiation therapy and increases survival, or improves quality of life for patients.

Cost is also a huge concern associated with proton therapy — and one reason so many hospitals are eager to jump into the proton therapy business. Medicare reimburses proton therapy at about twice the rate of standard radiation therapy, which prompts concerns that patients (or their insurers) could pay twice the price for a treatment that may be no more effective than the cheaper alternative.

This one would be paid for by a “a mix of capital, bonds and philanthropy,” according to Cleveland.com. What an obfuscation. No, it will be paid for with money! All of which has an opportunity cost. Dear Ohioans, you can do better with your money than throwing $30 million into this machine.

Open letter to Don Berwick at CMS:

Please make them stop. You can dry up this source of funds and improve health care and help control its escalating cost. Use the tools you have at hand.

We have great respect for former BI-Deaconess CEO Paul Levy. We’re particularly enamored by his insistence on administrative transparency and reimbursements for evidence-based therapies. Commonsense managerial goals like this that can do a lot to improve quality and reign in healthcare costs.

But, in an open letter on his blog, he asked CMS to stop the proton beam arms race. And, as gadget lovers and fans of science fiction, that was a little tough for us to stomach.

We’ve been following the application of proton beams ever since its appearance on Star Trek and were delighted to learn that doctors could use them for cancer therapy, as well. The idea is tumors can be destroyed or shrunk with more localized tissue irradiation than other external beam therapies.

The therapy is enormously expensive, and despite the operation of 29 proton beam centers worldwide and several decades of research, it’s not clear whether this therapy provides better outcomes (though it seems fewer side effects are noted).

Levy’s not arguing that proton beam therapy should stop, only that Medicare should stop reimbursing providers for using it until there is compelling evidence of its efficacy. And while that’s a reasonable argument, we can’t help but worry that limiting payments for this practice will limit its adoption, development and study. And that may leave us vulnerable when the Klingons attack.

Source : http://runningahospital.blogspot.in/2011/05/dear-cms-stop-proton-beam-arms-race.html

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Tryton Side Branch Coronary Stent Now in Larger Sizes in EU

Tryton Side Branch Coronary Stent Now in Larger Sizes in EU

Tryton Side Branch Coronary Stent Now in Larger Sizes in EU

DURHAM, N.C.–(EON: Enhanced Online News)–Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced receipt of CE Mark for larger-diameter sizes of the Tryton Side Branch Stent System™ for the treatment of coronary artery disease. Launch of the larger diameter size stents, 3.0 to 3.5mm and 3.5 to 4.0mm, has begun in Europe. The new sizes are designed for larger coronary vessels.

“With nearly 3,000 patients now treated and our randomized, multi-center pivotal trial enrolling patients in the United States, we continue to see positive momentum for the Tryton Side Branch Stent System”

“Current treatments for bifurcations have significant limitations, including higher rates of thrombosis – potentially fatal blood clots – and restenosis,” said Prof. Robert Van Geuns, associate professor, Erasmus Medical Center, Rotterdam, Netherlands. “Tryton’s Side Branch Stent System is an innovative solution to this persistent problem with impressive acute and long-term clinical outcomes. I am pleased that the launch of larger sizes of the Tryton Stent System will enable me to treat additional patients with bifurcations disease.”

“With nearly 3,000 patients now treated and our randomized, multi-center pivotal trial enrolling patients in the United States, we continue to see positive momentum for the Tryton Side Branch Stent System,” said Rick Anderson, board member of Tryton and managing director of PTV Sciences. “We are pleased that we have been able to respond to physicians’ requests for larger-diameter sizes of the device, enabling them to treat a larger portion of their patients with bifurcation disease.”

Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. Bifurcation lesions account for as many as one-third of all coronary lesions.1

About the Tryton Side Branch Stent

The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.

Clinical results from more than 500 patients with bifurcation lesions have consistently demonstrated target lesion revascularization (TLR) rates of less than four percent.

The stent system has received CE Mark approval in Europe and is commercially available in 21 countries throughout Europe and the Middle East. It is approved in the United States for investigational use only.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth- Hitchcock Medical Center) and Dan Cole to develop stents for the definitive treatment of bifurcation lesions. The Tryton Side Branch Stent System, approved for sale in Europe, is designed to offer a dedicated strategy for treating these challenging cases. Privately held, Tryton is backed by Arnerich Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest Ventures. For more information please visit www.trytonmedical.com.

Tryton Medical (Durham, North Carolina) has announced that the FDA issued the company Investigational Device Exemption (IDE) to complete a trial of company’s proprietary Side Branch Stent System™. tryton side stent Tryton Coronary Side Branch Stent System to Get U.S. Clinical TrialThe cobalt chromium device is designed to treat coronary atherosclerotic lesions occurring at vessel bifurcations. As we reported before, the system has already received marketing approval in Europe.

Some details of the planned trial:

The randomized, controlled study will compare the use of the Tryton stent in the side branch in conjunction with a standard drug eluting stent in the main vessel vs. the use of angioplasty in the side branch with a standard drug eluting stent in the main vessel for the treatment of complex bifurcation disease. The primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is percent diameter stenosis at nine months in the side branch vessel as assessed in an angiographic subgroup. Approximately 374 patients will undergo angiographic follow up at nine months. The study will also include an IVUS substudy in 96 patients with IVUS follow up at nine months. The study will enroll 700 patients at up to 75 centers in North America and Europe.

Tryton Medical has received CE Mark approval for the company’s larger sized side stents for treatment of coronary artery disease. The Tryton Side Branch System is now available in 3.0 to 3.5mm and 3.5 to 4.0mm sizes.

From the product page:

The Tryton Side Branch Stent System is designed to treat a wide spectrum of bifurcated lesions. The system’s highly deliverable stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel.

The Side Branch Stent features a low-profile cobalt chromium design compatible with 5F guide catheters. The stent’s unique three-zone design provides superior scaffolding within the side branch, radial strength in the transition zone, and minimal coverage in the main vessel zone.

Source : http://eon.businesswire.com/news/eon/20110518006090/en

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