Archive for September 22nd, 2012

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BD Ultra-Fine Needle with PentaPoint for Less Pain During Insulin Injections

BD Ultra-Fine Needle with PentaPoint for Less Pain During Insulin Injections

BD Ultra-Fine Needle with PentaPoint for Less Pain During Insulin Injections

Franklin Lakes, NJ (September 19, 2012) /PRNewswire/ — Studies suggest that as many as one-fifth to one-third of people with diabetes are hesitant or unwilling to give themselves insulin injections for reasons that include needle anxiety1, 2, 3. Patients who reported injection-related pain or embarrassment also admitted they intentionally skipped insulin injections more often3. A study by the American Association of Diabetes Educators (AADE) revealed that 47% of people with diabetes would be more likely to administer their injections regularly if a product were available that would ease the pain and discomfort of injections4. With these needs in mind, BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today the launch in the U.S. of the BD Ultra-Fine™ Nano Pen Needle with PentaPoint™ Comfort.

BD’s latest advancement in injection comfort, PentaPoint is a patented 5-bevel needle tip design that creates a flatter, thinner surface to help penetrate the skin with significantly greater ease. In a clinical home-use study, patients who inject insulin found BD’s 5-bevel pen needles to be significantly less painful, easier to insert, more comfortable and preferred overall when compared with current 3-bevel pen needles5. Bench tests showed the modified PentaPoint needle tip reduces the force to penetrate the skin by 23% compared to 3-bevel pen needles.

In recent years, advances in needle manufacturing technology, along with shorter and thinner needles, have been associated with progressively improving patient self-rating of injection comfort6. At 4mm by 32 gauge, BD Ultra-Fine Nano is the shortest, thinnest pen needle available, is clinically demonstrated to enhance comfort, and provides a less intimidating injection experience8. Combined with a one-handed injection technique and its ability to facilitate flexible site rotation, BD Ultra-Fine Nano may help improve adherence to diabetes therapy regimens to support better health outcomes. PentaPoint Comfort is an enhancement to BD Nano, reflecting that a modified needle tip can further advance patient comfort.

“BD Diabetes Care has been a leader in diabetes injection devices for over 85 years, and is committed to helping improve patients’ transition and adherence to injectable therapies by improving the efficacy, convenience and comfort of medication delivery. We are excited to provide another first-to-market innovation, designed to dramatically improve the injection experience for the millions of people living with diabetes,” commented Linda Tharby, President, BD Medical – Diabetes Care. “Building on the introduction of BD’s smallest needle, the BD Nano, we are confident that our new, patented PentaPoint Comfort technology will provide an even more comfortable injection experience. This will help enable patients to adopt and adhere more easily to the therapy regimens recommended to improve their outcomes.”

The AADE issued injection technique strategies that encourage the use of the smallest possible needle for improved patient comfort and insulin efficacy7. The BD Nano 4mm Pen Needle is proven to be as effective as longer needles for patients of various body types8, and provides equivalent glucose control by effectively delivering the insulin dose to subcutaneous tissue (the layer of fat below the skin), the recommended site for insulin injections9, and reducing the risk of injecting into muscle10. Intramuscular injection can accelerate insulin absorption and increase the risk of unanticipated hypoglycemia (abnormally low blood sugar)11, 12. Subcutaneous injection allows the insulin to be absorbed at an appropriate rate, resulting in better glycemic control13. For more information, visit www.bd.com/nano.

About Diabetes

Diabetes is a disease in which the body has a shortage of insulin or a decreased ability to use insulin, a hormone that allows glucose (sugar) to enter cells and be converted to energy. When diabetes is not controlled, glucose and fats remain in the blood and, over time, damage vital organs. Diabetes has become a national health concern in the United States, with an estimated 26 million people – 8.3 percent of the population – living with the disease. Of those people, an estimated 18.8 million have been diagnosed with diabetes, and another 7 million are thought to be undiagnosed. If current trends continue, as many as one of three U.S. adults will have diabetes by 205014. The total annual cost of diagnosed diabetes in the United States is an estimated $174 billion15.

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people’s health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

Greater Injection Comfort for People with Diabetes

BD’s NEW patented 5-bevel needle tip is designed

for more comfort.

Clinical trials support improved patient comfort,

easier insertion and overall preference.*

Sculpted to create a flatter, thinner surface that helps penetrate the skin with significantly greater ease for a smoother and gentler injection.

Click Here to See the Video

Experience on-the-go comfort!

The BD Nano 4mm x 32G pen needle, used with a single-hand,

no pinch technique, allows more flexibility to reach and rotate

to difficult-to-reach injection sites. The BD Nano is so short and

thin, it assures a comfortable injection experience. Ask your

doctor or pharmacist today!

BD has unveiled a new 4mm insulin injection needle that was designed to reduce the pain associated with daily bolusing. The Ultra-Fine Nano features the firm’s proprietary PentaPoint tip design that, by having extra bevels, promises a more comfortable injection.

The company hopes that by taking a bit of anxiety out injections they’ll be able to improve diabetics’ compliance with taking their insulin.

BD Ultra Fine Nano 4mm Pen Needle BD Ultra Fine Needle with PentaPoint for Less Pain During Insulin Injections (video)

BD’s latest advancement in injection comfort, PentaPoint is a patented 5-bevel needle tip design that creates a flatter, thinner surface to help penetrate the skin with significantly greater ease. In a clinical home-use study, patients who inject insulin found BD’s 5-bevel pen needles to be significantly less painful, easier to insert, more comfortable and preferred overall when compared with current 3-bevel pen needles. Bench tests showed the modified PentaPoint needle tip reduces the force to penetrate the skin by 23% compared to 3-bevel pen needles.

In recent years, advances in needle manufacturing technology, along with shorter and thinner needles, have been associated with progressively improving patient self-rating of injection comfort6. At 4mm by 32 gauge, BD Ultra-Fine Nano is the shortest, thinnest pen needle available, is clinically demonstrated to enhance comfort, and provides a less intimidating injection experience8. Combined with a one-handed injection technique and its ability to facilitate flexible site rotation, BD Ultra-Fine Nano may help improve adherence to diabetes therapy regimens to support better health outcomes. PentaPoint Comfort is an enhancement to BD Nano, reflecting that a modified needle tip can further advance patient comfort.

Source : http://www.multivu.com/mnr/58104-bd-ultra-fine-nano-pen-needle-with-pentapoint-comfort

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Omron electroTherapy TENS System for Pain Relief

Omron electroTherapy TENS System for Pain Relief

Omron electroTherapy TENS System for Pain Relief

LAKE FOREST, Ill., Sept. 18, 2012 /PRNewswire/ — Omron Healthcare, a leader in pain relief for more than 20 years, announced today a new electrotherapy solution for muscle and joint pain relief. The Omron electroTHERAPY Pain Relief unit (PM3030) is FDA cleared and now available to U.S. consumers without a prescription. Launched in conjunction with a new educational website, www.omronpainrelief.com, the pain solution is currently available at www.OmronWebstore.com and through several online retailers including, Amazon.com and Drugstore.com.

(Photo: http://photos.prnewswire.com/prnh/20120918/CG75739)

“As a pain management physician for 15 years, I’ve found electrotherapy to be a valuable pain management option,” said Dr. Rajive Adlaka, a board certified physician specializing in anesthesia and pain management. “One of the most important aspects of this therapy is that it’s 100 percent drug free. It essentially has no side effects and there’s no fear of addiction.”

Utilizing TENS (transcutaneous electrical nerve stimulation) technology, the same technology used by physical therapists for more than 30 years, the Omron electroTHERAPY device is easy to use and helps relieve pain wherever it is needed most. The pads for the Omron electroTHERAPY unit are placed near the site of the pain and safely deliver gentle, massage-like pulses to alleviate stiff, achy, or sore muscles and joints.

“There are as many as 100 million people in the U.S. with acute or chronic pain. Omron electroTHERAPY for Pain Relief may help alleviate their pain in as little as 15 minutes,” said Maureen Perou, senior product manager at Omron. “What’s different about this product is that it demystifies and simplifies a time-tested therapy. It’s like having a physical therapist by your side whenever you need it.”

Featuring three preset programs each with five levels of intensity, the simple controls allow for personalization according to the type of pain. This small, handy unit fits in your hand or pocket for use almost anywhere and includes two comfortable, Long Life pads that are good for up to 150 uses.

Suggested retail price for the device is $69.99. New Long Life replacement pads (set of 2) can be purchased for $19.99 at www.OmronWebstore.com. Currently available online, Omron electroTHERAPY will soon be in local drugstores across the country.

Omron Healthcare has been a global pain leader for more than 20 years, selling more than five million units worldwide since 2003. For more information, visit Omron’s new website at www.omronpainrelief.com.

About Omron Healthcare, Inc.

Omron Healthcare, Inc., is a leading manufacturer and distributor of personal wellness products. Omron’s market-leading products include home blood pressure monitors, fitness solutions, such as pedometers and heart rate monitors, and electrotherapy devices. In our connected and digital world, consumers’ want to accurately monitor and track certain aspects of their day-to-day health on- and offline. Omron products provide accurate health information that support positive lifestyle changes and can be shared with friends, family and other health professionals. For more information, visit www.omronhealthcare.com.

Omron electroTHERAPY Pain Relief is a simple, drug-free solution for relief of achy, stiff or sore muscle and joint pain. Available without a prescription, this easy-to-use TENS unit can help manage your pain in as little as 15 minutes exactly where you need it. It is one solution for multiple body pains.

Safe and effective, electroTHERAPY uses Transcutaneous Electrical Nerve Stimulation (TENS) technology to deliver gentle, massage-like pulses for on-the-spot pain relief. TENS therapy has been used by physical therapists and medical professionals for more than 30 years. Select the program that is right for your unique pain (arm, lower back or leg/foot) and adjust between five intensity levels.

Product Features

TENS TECHNOLOGY: Transcutaneous Electrical Nerve Stimulation (TENS) technology has been used by medical professionals such as physical therapists and chiropractors for more than 30 years

RELIEVES MULTIPLE BODY PAINS: Temporarily reduces pain in the lower back, arms, shoulders, legs, thighs, hips, feet, knees, elbows and ankles

PERSONALIZED THERAPY: 3 pre-set programs (arm, lower back, leg/foot), each with 5 intensity levels

SAFE & EFFECTIVE: FDA cleared and prescription free for home use

PORTABLE: Comfortably fits in your hand or pocket and can be used discretely anywhere

LONG LIFE PADS: includes comfortable, self-adhesive pads that are reusable up to 150 times with plastic holder for storage

PRODUCT INCLUDES: Omron electroTHERAPY unit, electrode cords, 2 Long Life pads, pad holder, 2 AAA batteries, instruction manual, quick start/pad placement guide

Omron Healthcare has released the new electroTHERAPY over-the-counter TENS (transcutaneous electrical nerve stimulation) system for temporary pain relief of muscles and joints.

The device can deliver three different preset programs at five levels of intensity that patients select between depending on the nature of their pain symptoms. Omron has setup a website to help people use the device and with positioning of the electrode pads for various common sources of pain.

Features from the product page:

TENS TECHNOLOGY: Transcutaneous Electrical Nerve Stimulation (TENS) technology has been used by medical professionals such as physical therapists and chiropractors for more than 30 years

RELIEVES MULTIPLE BODY PAINS: Temporarily reduces pain in the lower back, arms, shoulders, legs, thighs, hips, feet, knees, elbows and ankles

PERSONALIZED THERAPY: 3 pre-set programs (arm, lower back, leg/foot), each with 5 intensity levels

SAFE & EFFECTIVE: FDA cleared and prescription free for home use

PORTABLE: Comfortably fits in your hand or pocket and can be used discretely anywhere

LONG LIFE PADS: includes comfortable, self-adhesive pads that are reusable up to 150 times with plastic holder for storage

PRODUCT INCLUDES: Omron electroTHERAPY unit, electrode cords, 2 Long Life pads, pad holder, 2 AAA batteries, instruction manual, quick start/pad placement guide

Source : http://www.prnewswire.com/news-releases/omron-healthcare-announces-new-over-the-counter-electrotherapy-device-170156226.html

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Movation Total Knee Arthroplasty System from DJO

Movation Total Knee Arthroplasty System from DJO

Movation Total Knee Arthroplasty System from DJO

SAN DIEGO, CA, September 18, 2012 – DJO Global, Inc. (“DJO” or the “Company”), a leading provider of medical device solutions for musculoskeletal health, vascular health and pain management, announced that the first Movation™ Total Knee Arthroplasty (TKA) was implanted on Tuesday, September 4, 2012. The Movation Knee stems from a long tradition of Hospital for Special Surgery (HSS) excellence, complemented by a complete instrumentation system designed with simplicity and efficiency in mind.

The Movation Posterior Stabilized (PS, used in posterior cruciate ligament deficient knees) Knee design is licensed from the Hospital for Special Surgery (HSS) in New York, NY. HSS prides itself in being the largest joint replacement institution in the country, and also has earned an outstanding reputation for high quality engineering. DJO Surgical licensed this patent for a classic PS Knee solution, and re-defined it with modern innovative features, including a constant axis femoral component, contoured insert condyles for reduced rotational stress, reduced and rounded trochlear transition, and anatomic femoral and baseplate components.

Movation merges decades of successful clinical PS knee history with modern active patient requirements. “Patients needing a knee replacement are approaching surgeons with more demanding activity requirements,” said Bryan Monroe, Senior Vice President and General Manager of DJO Surgical. “Our goal was to develop a knee system with features that we know have historically performed extremely well, but also incorporate assets that allow TKA patients to remain active, such as high flexion allowance, enhanced stability through flexion, and e-plus™ vitamin E polyethylene.”

Instrumentation to implant the Movation Knee was a key focus of the design team. Reducing the overall quantity of instruments and making the instrument flow efficient can contribute to a reduced surgery time, which benefits the patient, the surgeon, and the hospital. Simple quick connect handles, color coded buttons, and magnetic attachments contribute to the smooth flow and reliability of the procedure.

Dr. Barry Waldman, co-designer of the Movation Knee and Orthopedic Surgeon at Sinai Hospital in Baltimore, MD, stated “Our team was very excited to perform our first Movation TKA. This timeless PS knee solution combines easy to use instrumentation with upgraded PS Knee features that I believe will give our patients more stability and deeper flexion than we could obtain in the past. I am looking forward to seeing more of our patients benefit from this new innovation.”

The Movation System will be fully launched at AAOS 2013, and will include e-plus blended vitamin E polyethylene which provides long-term wear benefits to TKA patients.

About DJO Global

DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare®, DJO® Surgical and Dr. Comfort®.

DJO Global has launched the Movation, a total knee arthroplasty (TKA) system developed at the Hospital for Special Surgery in New York City. The company licensed the technology and added a few features of its own to improve comfort and performance.

The system comes with a newly developed instrument set that was designed for easier and more efficient implantation.

More about the Movation from the announcement:

DJO Surgical licensed this patent for a classic PS Knee solution, and re-defined it with modern innovative features, including a constant axis femoral component, contoured insert condyles for reduced rotational stress, reduced and rounded trochlear transition, and anatomic femoral and baseplate components.

Movation merges decades of successful clinical PS knee history with modern active patient requirements. “Patients needing a knee replacement are approaching surgeons with more demanding activity requirements,” said Bryan Monroe, Senior Vice President and General Manager of DJO Surgical. “Our goal was to develop a knee system with features that we know have historically performed extremely well, but also incorporate assets that allow TKA patients to remain active, such as high flexion allowance, enhanced stability through flexion, and e-plus™ vitamin E polyethylene.”

Instrumentation to implant the Movation Knee was a key focus of the design team. Reducing the overall quantity of instruments and making the instrument flow efficient can contribute to a reduced surgery time, which benefits the patient, the surgeon, and the hospital. Simple quick connect handles, color coded buttons, and magnetic attachments contribute to the smooth flow and reliability of the procedure.

Source : http://www.djoglobal.com/investors/press-releases/djo-surgical-business-unit-djo-global-announces-launch-movation-knee-system

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AIM 3D Needle Placement Software from InnerOptic

AIM 3D Needle Placement Software from InnerOptic

AIM 3D Needle Placement Software from InnerOptic

Precise needle placement using ultrasound is extremely difficult, due to poor visiblity and complex hand-eye coordination. Device misplacement results in multiple “stabs,” lengthy procedures, patient injury, and incomplete interventions. The resulting injuries cost over $1B to repair annually, and these errors are the leading cause of malpractice claims against general surgeons.

Better visualization would enable more image-guided procedures to be performed with greater success.

The Solution: InnerOptic’s AIM 3D Targeting Software

InnerOptic’s FDA-approved and patented AIM Software is a “GPS for Needle Guidance,” enhancing the physician’s ability to easily, quickly and precisely place a needle (e.g., ablation antenna, biopsy needle, catheter introducer, etc.) with ultrasound imaging.

InnerOptic’s AIM 3D software improves the accuracy of needle-based interventions, reduces injuries, and shortens procedure times, resulting in better patient outcomes.

AIM provides needle guidance for a

liver tumor ablation surgery.

InnerOptic’s AIM solves the spatial coordination problem inherent in ultrasound-guided interventions. The AIM software continually monitors the positions of the needle and of the ultrasound transducer, displaying their real-time positions in an intuitive user interface on a 3D stereoscopic monitor.

Improved physician performance has been demonstrated in multiple scientific studies and in a successful clinical trial.

AIM’s Benefits include:

• Easier, safer, faster, more precise interventions

• Lower error and injury rates

• High reimbursements with an existing CPT code

• Easiest, most intuitive user interface

• Intuitive “freehand” device placement

• 3D interface restores hand-eye coordination

• Easy integration into existing imaging systems

• Covered by multiple patents

• FDA Approved

• Improved patient outcomes

AIM Enchances Image-Guided Interventions

InnerOptic’s AIM 3D guidance software addresses the over 27 million image-guided procedures performed annually in the US alone. AIM provides guidance for any needle-based intervention using ultrasound imaging, including catheterizations, nerve blocks, in vitro fertilizations, tumor ablations and biopsies. AIM supports open, percutaneous and laparoscopic interventions.

As shown in the first video below, AIM improves needle-placement accuracy by rendering needle trajectory markers, the needle-ultrasound intersection point (purple square), and the needle trajectory (yellow “markers” in front of the needle)..

AIM also supports “out-of-plane” needle insertions, giving the surgeon or radiologist the flexibility to accurately place the biopsy/ablation probe at any angle relative to the ultrasound image.

AIM assisting Dr. David Iannitti to accurately place a needle

during surgery to ablate liver tumor lesions.

The AIM software displays an ablation volume guide (red and orange “cage” in the video below). The ablation volume guide shows the physician which tissue area may be ablated, before the ablation takes place. This provides the physician with the confidence that the ablation needle/antenna is properly positioned, maximizing the destruction to the tumor while minimizing the damage to healthy tissue. As shown below, The ablation field is identified by AIM as the tumor is visualized with the use of color flow Doppler imaging.

InnerOptic Technology (Hillsborough, NC) received FDA 510(k) clearance to bring to market its AIM software for ultrasound guided needle placement. AIM takes advantage of electromagnetic tracking to display the locations of the needle and ultrasound transducer on a 3D monitor. Inneroptic AIM AIM 3D Needle Placement Software from InnerOpticThe technology can help physicians perform all sorts of image guided procedures including catheterizations, nerve blocks, in vitro fertilizations, tumor ablations and biopsies. The system is also compatible with laparoscopic interventions.

The software is currently compatible with ultrasounds from BK Medical and Aloka, as well as interventional devices from Halt Medical and Microsulis.

From the product page:

The AIM software displays an ablation volume guide. The ablation volume guide shows the physician which tissue area may be ablated, before the ablation takes place. This provides the physician with the confidence that the ablation needle/antenna is properly positioned, maximizing the destruction to the tumor while minimizing the damage to healthy tissue. As shown below, The ablation field is identified by AIM as the tumor is visualized with the use of color flow Doppler imaging.

Source : http://www.inneroptic.com/AIM.html

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New Radioisotope Supplier to Fill Gaping Hole in Market

New Radioisotope Supplier to Fill Gaping Hole in Market

New Radioisotope Supplier to Fill Gaping Hole in Market

ST. LOUIS, Mar 11, 2010 (BUSINESS WIRE) — Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor (Maria) in Poland as a site to irradiate highly-enriched uranium targets for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99 obtained from Maria in the manufacture of its Technetium 99m (Tc 99m) generators. Patients should begin to benefit from Maria-produced Mo 99 in the United States and Canada later this month.

Tc 99m is a vital medical isotope used in over 80 percent of all nuclear medicine diagnostic and functional studies of organs and anatomical systems. The information from these studies is used by many medical specialists (including radiologists, nephrologists, oncologists and cardiologists) to better diagnose and treat patients. More than 35 million nuclear medicine procedures are performed worldwide each year, more than half in the United States.

On February 17, 2010, in Warsaw, Poland, Covidien and the Institute of Atomic Energy in Poland (IAE POLATOM) announced an agreement for Maria to begin supplying Mo 99. At the time, it was estimated that the Mo 99 supplied from Maria would help meet the needs of more than one million additional patients worldwide in just the first six months.

“We are pleased that both FDA and Health Canada expedited their reviews of our data, resulting in a quick approval,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “Their actions are great news for patients who may have been facing longer delays in receiving critical nuclear medicine diagnostic procedures.”

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business and www.covidien.com/Mo99supply to learn more about Mo 99 supply.

Forward-Looking Statements

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, the possibility that the Maria Research Reactor may not be able to supply Mo 99 in a volume or form sufficient to meet our needs or at all, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

Due to the continued closure of Canada’s Chalk River reactor, a major supplier of medical radioisotopes, and the historic limited capacity within the nuclear medicine supply industry, there has been a serious shortage of radiomarkers on the market.

To address this problem, Covidien just received the FDA go ahead to source molybdenum-99 radioisotope from Poland’s Maria nuclear research reactor (pictured) to produce technetium-99m for medical applications.

The fairly short lived isotope is used in approximately 80% of nuclear diagnostic procedures, and the initial supply, which should be available next month in the US and Canada, should provide enough material for one million procedures in the first six months.

Source : http://investor.covidien.com/phoenix.zhtml?c=207592&p=RssLanding&cat=news&id=1401493

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ViewRay Receives FDA Clearance for MRI-Guided Radiation Therapy System

ViewRay Receives FDA Clearance for MRI-Guided Radiation Therapy System

ViewRay Receives FDA Clearance for MRI-Guided Radiation Therapy System

News

Siteman Cancer Center at Barnes-Jewish and Washington University Begins Imaging with ViewRay System

ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System

ViewRay Names Michael Brandt Senior Vice President of Sales

Product

Motion, Managed

The System

The Software

Treatment Process

Position Patient

Predict & Optimize Dose

Target Soft Tissue

Review & Assess

ViewRay has received FDA premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer, providing continuous soft-tissue imaging during treatment so that clinicians can see and record precisely where radiation therapy is being delivered, as it is being delivered.

Radiation therapy treatment plans are based on previously acquired static imaging such as CT or PET/CT. Motion correction has historically been done with markers applied to the body and more recently with image-guided radiation therapy, where CT scans or X-rays are acquired moments before the initiation of radiotherapy. These systems, however, have the disadvantage of introducing an additional radiation dose and not being able to visualize the tumor in real-time.

By using real-time MRI, the Viewray system shows soft-tissue as it is being treated and adjusts for its movement in real time, without using any additional radiation. Radiotherapy is only delivered when the system detects that the target tissue is within the radiation target area. In addition, it helps clinicians keeping track of the delivered dose of radiation to avoid normal tissues and critical structures such as the spinal cord by allowing for on-the-fly treatment plan re-optimization.]

Viewray screenshot ViewRay Receives FDA Clearance for MRI Guided Radiation Therapy SystemThe ViewRay system is primarily intended for treatment of tumors that are likely to move significantly during treatment. This includes thoracic, abdominal and pelvic malignancies, such as lung, prostate, liver and head and neck cancer. ViewRay’s corresponding treatment planning and delivery software already received FDA premarket notification clearance in 2011.

The first ViewRay system is installed at the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, where early imaging studies have taken place. Additional ViewRay partners include the UCLA Jonsson Comprehensive Cancer Center and the University of Wisconsin Carbone Cancer Center, where a ViewRay system is currently being installed.

Source : http://www.viewray.com/

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CRE Wireguided Balloon Dilator FDA Cleared for Stone Extraction in Biliary Duct

CRE Wireguided Balloon Dilator FDA Cleared for Stone Extraction in Biliary Duct

CRE Wireguided Balloon Dilator FDA Cleared for Stone Extraction in Biliary Duct

NATICK, Mass., May 29, 2012 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announces the U.S. Food and Drug Administration has cleared an expanded use indication for the CRE™ Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy. The new indication offers physicians the ability to now perform Dilation Assisted Stone Extraction (DASE) with the CRE Wireguided Balloon Dilator. This is an alternative method for the removal of difficult stones in the biliary duct.

“Since becoming available, the DASE procedure with the CRE Wireguided Balloon has significantly changed my approach to the endoscopic removal of large common bile duct stones. It is an easy-to-use technique, and I have had great success in managing difficult stones,” said Kenneth Sigman, M.D., at Birmingham Gastroenterology Associates in Birmingham, AL. “The CRE Wireguided Balloon is easy to place and is consistent and reliable for inflation size and pressure. I am very comfortable with this balloon for the DASE application as I’ve been using it for many years for esophageal and gastric stenosis.”

The CRE Wireguided Balloon Dilator is constructed of Pebax® to provide durability and flexibility, and is designed to gradually open strictures by delivering three distinct pressure-controlled diameters in a single balloon. The rounded-shoulder design of the balloon is engineered to help facilitate endoscopic visualization or balloon endoscopy and provide greater usable balloon surface area during dilation.

“Large stone extraction with DASE is easy, procedures are completed faster, and I have achieved a high rate of complete stone clearance,” said Riad Azar, M.D., Barnes Jewish Hospital, St. Louis, MO. “The technique is easy to learn, and I have taught a number of referring physicians who are now doing it successfully.”

“The CRE Wireguided Balloon Dilator for the DASE procedure provides a new and alternative endoscopic therapy for the more than 60 million people worldwide affected by the presence of stones in the common bile duct,” said David Pierce, president of the endoscopy division at Boston Scientific. “The CRE Wireguided Balloon Dilator is a core product in our endoscopy portfolio, and it underscores our ongoing commitment to advancing treatments that meet the needs of patients and physicians.”

The CRE Wireguided Balloon Dilator is also indicated to dilate narrowed areas (or strictures) in the digestive tract.

For more information on the CRE Wireguided Balloon Dilator, visit Global Endoscopy Resources on-line at www.bostonscientific.com/endo-resources.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new indications for our products, regulatory approvals, our business plans, markets for our products and product performance. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Boston Scientific received FDA clearance to expand the use of the company’s CRE Wireguided Balloon Dilator to endoscopic dilation of the Sphincter of Oddi (aka sphincter of ampulla) following sphincterotomy, permitting Dilation Assisted Stone Extraction (DASE), an alternative method of purging stones in the biliary duct.

The dilator offers three pressure-controlled dilation sizes that can be set by the physician and is shaped to allow for easy placement, help with endoscopic visualization and for use in balloon endoscopy.

In the press release, Kenneth Sigman, M.D., at Birmingham Gastroenterology Associates in Birmingham, AL, is quoted as saying,

“Since becoming available, the DASE procedure with the CRE Wireguided Balloon has significantly changed my approach to the endoscopic removal of large common bile duct stones. It is an easy-to-use technique, and I have had great success in managing difficult stone. The CRE Wireguided Balloon is easy to place and is consistent and reliable for inflation size and pressure. I am very comfortable with this balloon for the DASE application as I’ve been using it for many years for esophageal and gastric stenosis.”

Source : http://bostonscientific.mediaroom.com/2012-05-29-Boston-Scientific-Announces-Expanded-Indication-For-CRE-Wireguided-Balloon-Dilator

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Laser-Powered Microbots Gently Transport Live Cells

Laser-Powered Microbots Gently Transport Live Cells

Laser-Powered Microbots Gently Transport Live Cells

We’re used to thinking of robots as mechanical entities, but at very small scales, it sometimes becomes easier to use existing structures (like microorganisms that respond to magnetic fields or even swarms of bacteria) instead of trying to design and construct one (or lots) of teeny tiny artificial machines. Aaron Ohta’s lab at the University of Hawaii at Manoa has come up with a novel new way of creating non-mechanical microbots quite literally out of thin air, using robots made of bubbles with engines made of lasers.

To get the bubble robots to move around in this saline solution, a 400 mW 980nm (that’s infrared) laser is shone through the bubble onto the heat-absorbing surface of the working area. The fluid that the bubbles are in tries to move from the hot area where the laser is pointing towards the colder side of the bubble, and this fluid flow pushes the bubble towards the hot area. Moving the laser to different sides of the bubble gives you complete 360 degree steering, and since the velocity of the bubble is proportional to the intensity of the laser, you can go as slow as you want or as fast as about 4 mm/s.

This level of control allows for very fine manipulation of small objects, and the picture below shows how a bubble robot has pushed glass beads around to form the letters “UH” (for University of Hawaii, of course):

Besides being able to create as many robots as you want of differing sizes out of absolutely nothing (robot construction just involves a fine-tipped syringe full of air), the laser-controlled bubbles have another big advantage over more common microbots in that it’s possible to control many different bubbles independently using separate lasers or light patterns from a digital projector. With magnetically steered microbots, they all like to go wherever the magnetic field points them as one big herd, but the bubbles don’t have that problem, since each just needs its own independent spot of light to follow around.

The researchers are currently investigating how to use teams of tiny bubbles to cooperatively transport and assemble microbeads into complex shapes, and they hope to eventually develop a system that can provide real-time autonomous control based on visual feedback. Eventually, it may be possible to conjure swarms of microscopic bubble robots out of nothing, set them to work building microstructures with an array of thermal lasers, and then when they’re finished, give each one a little pop to wipe it completely out of existence without any mess or fuss.

Cooperative Micromanipulation Using Optically Controlled Bubble Microrobots by Wenqi Hu, Kelly S. Ishii, and Aaron T. Ohta of the the Department of Electrical Engineering, University of Hawaii at Manoa, was presented last week at the 2012 IEEE International Conference on Robotics and Automation in St. Paul, Minn.

Microrobots

This project involves the manipulation and the assembly of micro-objects using optically controlled microrobots. Light patterns are used to control the movement of the microrobots. Objectives include the micro-assembly of objects, including live cells, and the parallel, independent control of multiple microrobots in one system.

At the 2012 IEEE International Conference on Robotics and Automation, researchers from the University of Hawaii showed off amazing new bubble microbots they created purely out of air.

The tiny bubbles are powered and directed within a saline solution by an infrared laser. The technique relies on heating the solution with the laser at the periphery of the bubble causing the liquid to want to flow away from the warm spot and propelling the bubble toward it.

The team demonstrated that live cells encapsulated within hydrogel blocks can be ferried around with great precision without doing them any harm. See for yourself in this video from University of Hawaii’s Microdevices & Microfluidics Lab.

Source : http://spectrum.ieee.org/automaton/robotics/industrial-robots/microbots-made-from-bubbles-and-lasers

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Draeger Infinity Acute Care System Coming to North America

Draeger Infinity Acute Care System Coming to North America

Draeger Infinity Acute Care System Coming to North America

Telford, PA – Today Dräger announced the availability of its breakthrough Infinity Acute Care System monitoring solution in the United States and Canada*. This system pairs a handheld device for monitoring at the bedside and in-hospital transport with a widescreen medical workstation at the point of care. The system provides continuous surveillance, interoperability with Dräger’s ventilation systems, comprehensive patient information at the bedside, and the full suite of Masimo’s rainbow® SET noninvasive Pulse CO-Oximetry measurements, which can help hospitals increase patient safety and reduce costs. The Infinity Acute Care System has been in commercial use in European hospitals since 2010.

Medical technology brings many benefits to the delivery of patient care, but it can also add unwelcomed complexity for caregivers. As a result, clinicians often spend more time dealing with technical interfaces and complicated workflow and less time focusing on direct patient care.

“At Dräger, our response to increased technical and clinical complexity is to explore ways we can simplify acute care delivery for clinicians,” says Marita Klafke, President, Draeger Medical Systems Inc. “The Infinity Acute Care System monitoring solution is designed to help streamline workflow so that the clinician can focus on the needs of the patient.”

First installation at Rush University Medical Center

The highly rated Rush University Medical Center in Chicago is the first US hospital to fully incorporate this advanced new patient monitoring system. Dräger worked closely with Rush staff as they developed the hospital’s new 376-bed building known as the Tower, where Dräger’s monitoring and IT technology is installed in 304 acute and critical care rooms.

The monitoring solution consists of a handheld Infinity M540 patient monitor integrated with the Dräger Medical Cockpit®. The M540 transitions seamlessly from the bedside to wireless transport, eliminating the time consuming process of changing monitors and cables. The Medical Cockpit integrates vital signs data from the M540, together with networked information such as patient history, diagnostic images, lab results, and other relevant networked clinical information into one widescreen display at the point of care. The system also enables ventilation parameters from Dräger ventilators to be displayed on the Medical Cockpit and sent over the network.

Wireless on transport

This fully networked solution allows a single monitor to accompany the patient during the entire care pathway to minimize undetected events. When the Infinity M540 is undocked at the bedside, it automatically switches to wireless and broadcasts patient vital signs data to the Infinity Network allowing uninterrupted monitoring during transport on the Infinity CentralStation. At the same time, it opens the flow of patient information throughout the hospital and beyond to support time-critical decision making.

Masimo rainbow® SET technology for noninvasive, continuous Pulse CO-Oximetry measurements

The Infinity M540 integrates Masimo rainbow® SET technology – a new monitoring platform that noninvasively and continuously measures multiple blood components and hemodynamic parameters that previously required invasive procedures. Dräger is one of the first major monitoring vendors to offer the full suite of Masimo’s rainbow® SET Pulse CO-Oximetry measurements.

The Infinity Acute Care System monitoring solution is manufactured by Draeger Medical Systems, Inc. in Andover, Massachusetts for Draeger Medical GmbH.

Dräger. Technology for Life®

Dräger is a leading international company in the fields of medical and safety technology. Dräger products protect, support and save lives. Founded in 1889, in 2011 Dräger generated revenues of around EUR 2.26 billion. The Dräger Group is currently present in more than 190 countries and has about 12,000 employees worldwide. Please visit www.draeger.com for more information.

At Dräger, our response to increased technical and clinical complexity is to look at ways we can simplify our solutions so clinicians can easily access the data they need to make informed clinical decisions. The result is the Infinity® Acute Care System monitoring solution, which teams the handheld Infinity M540 patient monitor with the powerful Dräger Medical Cockpit® that integrates diverse clinical information at the point of care.

Dräger is bringing its Infinity Acute Care System, an advanced ICU monitoring package, to the U.S. and Canada. The system features a wireless patient monitor that stays attached to the bed, allowing for quick movement of patients between different clinical departments without ever losing live data feeding back to the central console.

The Infinity includes Masimo’s complete rainbow SET noninvasive Pulse CO-Oximetry, interfaces with Dräger’s ventilators, and the “Medical Cockpit” integrates the data with information from the EMR including diagnostic images and patient history.

Details of the Infinity Acute Care System from the product page:

Infinity M540 Patient MonitorDraeger Infinity M5401 Draeger Infinity Acute Care System Coming to North America

Handheld

Lightweight, durable and reliable (1.2 kg / 2.6 lbs, including battery)

System connectivity

Provides system networking and communication between the M540 and Medical Cockpit via the P2500 Power Supply

Water-resistant

Splash-resistant and submersible for protection against fluids

Wireless transport

Undocks at the bedside with the press of a but ton for transport, then automatically sends data wirelessly to the Infinity Network

Portable

Accompanies the patient throughout the hospital and in a land ambulance

Infinity M500 Docking Station

System connectivity

Provides system networking and communication between the M540 and Medical Cockpit via the P2500 Power Supply

Rechargeable

Powers the M540 when docked, recharging the internal battery for transport

Draeger Infinity M540 full1 Draeger Infinity Acute Care System Coming to North AmericaInfinity Medical Cockpit

360° alarm light

Enables caregivers to see alarms from anywhere in the room

Integrated information

Provides easy access to vital signs data, clinical applications, the hospital network, and the intranet at the point of care

Widescreen display

Large 20” (C700) or 17” (C500) touch-screen display makes information easy to see from any angle

Infection-resistant

Fanless, easy-to-clean design reduces risk of cross-contamination

Source : http://www.jems.com/article/product-announcements/dr-ger-launches-breakthrough-infinity-ac

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Diabetes Design Demo Day Semi-Finalist: N4A Diabetes Care Center

Diabetes Design Demo Day Semi-Finalist: N4A Diabetes Care Center

Diabetes Design Demo Day Semi-Finalist: N4A Diabetes Care Center

nnovation! Experience! Expertise! Share yours with Aging Network colleagues at the n4a 38th Annual Conference & Tradeshow in Louisville, KY! Deadline: Monday, October 29.n4a’s new network for e-learning offers aging professionals access to our resource library, discussion forums, events calendar, emerging models, presentations, webinars and more.

Among all the semi-finalists for Sanofi’s Data Design Diabetes Demo Day, we think N4A Diabetes Care Center was the most unexpected and confusing. N4A dates back to 1960?s legislation on aging, and is a loose affiliation of state agencies around aging. N4A literally stands for Advocacy, Actions, and Answers on Aging.

As Sandra Mark Woods explained in her presentation, they’re not an app, not software, nor offering live streaming, but they are a data-driven organization and “high-touch” in diabetes management. N4A is a Title VI organization that has been providing services in communities for decades. They are involved in Meals-on-Wheels, depression counseling, transport of patients to providers, and chronic disease management services. Millions use it, they have 800 million patient records and a diabetes index with 30 million maps.

They note that 80% of diabetics live in just 8000 zip codes (out of 38,000). They also note that most diabetics under-consume healthcare resources, then have a big, bad event (at sadly predictable rates) and end up over-consuming resources. They aim to stop this progression from under to over consumption. It’s a death march.

The uncontrolled diabetic is living at about a 18% risk of hospitalization (per year?) representing a 2000% increase in healthcare costs when he or she lands in a hospital. Noncompliance and underutilization is not cost-effective, when the reason is lack of transportation, or a fear of needles.

N4A will be culturally sensitive, locally tailored to patient needs. They already know in each zip code how many diabetics will end up in ED, how many will end up as inpatients, and know how many diabetics are at risk and not doing enough to stop it.

For all this time, N4A has lived off grants, but now with Diabetes Care Center they’re moving into business. Their plan is fee for service, insurer contracts, and value-sharing by avoiding acute events. They figure if they spend $1000 per enrollee (netting about $360 profit) to save on a $35k event, everyone will win. And others can’t compete with their data and reach. When someone in the audience asked, who pays the $1000 per enrollee (since they’re not employer based) the N4A folks answered: the insurer, or a sponsor, or an ACO. Each payer will see ROI.

The question that got to the heart of our confusion was: aren’t they already doing this work, as a nonprofit? Well, it turns out: No… Their nonprofit side collects data, the new for-profit side targets the individuals and tries to prevent hospitalizations.

It’s a brave new world, where a 40+ year-old bureaucracy with reams of patient data can compete in a startup innovator challenge. But if that’s what it takes to improve diabetes care, we’ll endorse it.

Source : http://www.n4a.org/

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