Posts Tagged ‘medical-gadget-blog’

Page 1 of 41234

MicroCHIPS Announces Clinical Results for First Successful Human Trial Of Implantable, Wireless Microchip Drug Delivery Device

MicroCHIPS Announces Clinical Results for First Successful Human Trial Of Implantable, Wireless Microchip Drug Delivery Device

MicroCHIPS, an MIT spin-out company out of Waltham, MA, has announced results of a clinical study evaluating its wirelessly controlled implantable drug releasing electronic microchip. The device features controllable reservoir arrays that can contain a drug or a microsensor.  The reservoirs can be opened and closed either based on a preset program, activated wirelessly through a transmitter, or based on readings of the embedded sensors.drug-delivery-microchip

The current study focused on delivering teriparatide for post menopausal women suffering from osteoporosis.  Normally these women would have to receive an unpleasant daily injection of the drug, but thanks to the MicroCHIPS device, they received a well controlled regular dose with little perceived discomfort.

Details from the press release:

In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.

The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.

The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes,” said treating surgeon Pia Georg Jensen, MD. “The patients were able to walk out of the facility and go home unescorted.”

To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.

“These data validate the microchip approach to multi-year drug delivery without the need for frequent injections, which can improve the management of many chronic diseases like osteoporosis where adherence to therapy is a significant problem,” said study lead author Robert Farra, MicroCHIPS President and Chief Operating Officer. “We look forward to making further progress to advance our first device toward regulatory approvals, as well as developing a range of products for use in important disease areas such as osteoporosis, cardiovascular disease, multiple sclerosis, cancer, and chronic pain.”

In the trial, post menopausal women diagnosed with osteoporosis received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection. The drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood to what is observed from standard, recommended multiple subcutaneous injections of teriparatide.

In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.

The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.

The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes,” said treating surgeon Pia Georg Jensen, MD. “The patients were able to walk out of the facility and go home unescorted.”

To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.

“A microchip that continues to deliver teriparatide with this or similar consistency and efficiency over 12 to 24 months could improve bone mass, density, architecture, and strength,” said study co-author Robert Neer, Founder & Director of the Massachusetts General Hospital Bone Density Center and Associate Professor of Medicine at Harvard Medical School.

Implantable medical devices such as pacemakers and pain pumps perform important functions to help patients return to a healthier state and to manage their disease. The design of a next-generation microchip drug delivery device is the only approach to an implantable device that can be wirelessly programmed to release drugs inside the body without percutaneous connections in or on the patient. An implantable microchip device also provides real-time dose schedule tracking, and as part of a network, physicians can remotely adjust treatment schedules as necessary.

“This trial demonstrates how drug can be delivered through an implantable device that can be monitored and controlled remotely, providing new opportunities to improve treatment for patients and to realize the potential of telemedicine,” said study co-author Robert Langer, ScD, Institute Professor at the David H. Koch Institute for Integrative Cancer Research at MIT, and cofounder of MicroCHIPS, Inc. “The convergence of drug delivery and electronic technologies gives physicians a real-time connection to their patient’s health, and patients are freed from the daily reminder, or burden, of disease by eliminating the need for regular injections.”

MicroCHIPS is currently developing new designs of its microchip-based implant to include as many as 400 doses per device providing daily dosing for one year or multi-year therapy for less frequent dosing regimens. Components of the original microchip technology, such as the array of micro reservoirs used to contain drug and the first microchip opening mechanism, were developed at the Massachusetts Institute of Technology and licensed to MicroCHIPS.

Source:http://www.mchips.com/12_Feb_16_pr.html

Full story

Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™

Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™

The FDA granted pre-market approval to St. Jude Medical for the company’s Therapy Cool Path Duo and Safire Blu Duo cardiac ablation catheters and the matching IBI1500T9-CP V1.6 generator to power them.Therapy-Cool-Path-Duo

The catheters provide cooling irrigation all around the tip from a dozen ports so that only targeted tissue is destroyed.  The system is already cleared for marketing in Europe.

Some of the features:

  • Externally irrigated ablation catheter with additional irrigation ports for more uniform cooling
  • Lower average measured tip temperature at equivalent flow rates compared to distal tip irrigation only 
  • Fewer incidences of coagulum and charring observed in preliminary study
  • All-braided construction provides uninterrupted torque transfer for more responsive handling
  • M, L, XL, and L1 curve configurations

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generato
PMA Applicant: Irvine Biomedical, Inc., A St. Jude Medical Company
Address: 2375 Morse Ave., Irvine, CA 92614
Approval Date: January 25, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110016a.pdf

What is it? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia) called typical atrial flutter by finding the source of the rhythm disturbance and destroying (ablating) small areas of the heart tissue. The catheters take energy from an external source (the IBI1500T9-CP V1.6 Cardiac Ablation Generator) to a point in the right side of the heart.

How does it work? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is inserted into a blood vessel (artery or vein), usually though a site in the upper leg or neck. The catheter is manually advanced through the blood vessels until it reaches the correct location inside the heart. The tip of the catheter is moved around by a mechanism on the handle. Inside the heart, electrodes at the tip gather data that pinpoint the location of the faulty tissue in the heart (electrical mapping). Once the site is identified, the device delivers radiofrequency (RF) energy to destroy the small areas of tissue that blocks the heart’s internal electrical signals that cause the typical atrial flutter. The catheters are removed after treatment.

When is it used? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter, and the IBI 1500T9-CP V1.6 Cardiac Ablation Generator are used to destroy small areas in the heart that cause an abnormally fast heart beat or abnormal heart rhythm in the upper chambers (the atria) of the heart. The technical name for this kind of abnormal heart beat is typical atrial flutter.

What will it accomplish? Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm, and in other cases, can reduce the frequency of episodes that a patient experiences. In a clinical study involving 188 patients, the abnormal rhythm (typical atrial flutter) was corrected in 181 patients (96%) for 7 days after treatment; and it remained corrected after 3 months in 174 patients (94.5%).

When should it not be used? The device should not be used in patients:

Full story

Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump

Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump

Medasys has received FDA pre-market approval for its Prometra programmable implantable drug pump. The Prometra is a non-peristaltic programmable implantable pump that delivers INFUMORPH (preservative-free morphine sulfate sterile solution) intrathecally for the management of pain.Medasys-Prometra-morphine-pump

The Prometra makes use of a valve gated precision dosing system to achieve high accuracy, minimizing dose variations due to temperature, pressure, flow rate, or reservoir fill levels. It has a minimal amount of moving parts and no complex gears and rotors.

The pump is implanted near the spine and has a microcatheter that runs to the intrathecal area of the lower spine. The intrathecal delivery makes it possible to use very low doses compared to other routes of administration, thus minimizing the risk of side-effects and lowering the amount of medication needed in the reservoir. The reservoir can be refilled percutaneously with a syringe and a needle.

MOUNT OLIVE, N.J., Feb. 13, 2012 /PRNewswire/ – Medasys Inc., a medical device company focused on providing implantable drug delivery solutions, announced today that it has received PMA approval from the U. S. Food and Drug Administration (FDA)  for its Prometra® programmable implantable drug pump.   Prometra will be the first non-peristaltic programmable implantable pump that has received FDA approval for delivery of INFUMORPH (preservative-free morphine sulfate sterile solution).  INFUMORPH is indicated for intraspinal administration for the management of pain.

In addition to meeting all of the PMA safety and effectiveness requirements, a clinical trial demonstrated 97% clinical accuracy in the delivery of the physician-programmed dose, the highest labeled accuracy available for this type of pump.

“We are pleased to be able to utilize our engineering expertise and intellectual property to advance intrathecal therapy in the U.S.,” Steve Adler, President and CEO of Medasys commented. “Prometra represents the first significant evolution in pump technology available in the US in over 15 years.”

Advances in the Prometra pump design are intended to maximize device longevity and dose delivery accuracy. By reducing the number of moving parts and eliminating complex gears and rotors, pump dependability and reliability should be greatly improved. The Prometra also makes use of a patented valve gated precision dosing system to achieve extremely high accuracy, minimizing dose variations due to temperature, pressure, flow rate, or reservoir fill levels. It is expected that the combination of these factors will contribute to improved pain management.

It is estimated that 116 million people in the U.S. suffer with chronic pain. Continuous intrathecal delivery of INFUMORPH using a microinfusion device (e.g., implantable drug delivery pump) is a therapeutic option used for the management of chronic pain.  Chronic pain can be debilitating, disabling, and negatively impact quality of life. The Prometra offers patients and physicians a new highly accurate option for drug delivery.

About Medasys
Medasys’ strategic goal is to become the leading implantable drug delivery company in the world. Founded in 2005, Medasys received approval to conduct its first clinical trial in 2007 on the Prometra programmable implantable pump. Medasys received approval by the FDA to market the Prometra in 2012. Medasys has been granted multiple patents, and is focused on working closely with physicians to rapidly improve the capabilities of implantable drug delivery and management systems.

For more information see the Medasys web site at: http://www.MedasysPumps.com.

Forward-Looking Statements
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, reimbursement policies, commercialization of new technologies, intellectual property, and other factors.

Source:http://www.prnewswire.com/news-releases/medasys-inc-announces-fda-approval-for-implantable-programmable-drug-pump-139208249.html

Full story

Cellnovo Launches World First Mobile-Connected Diabetes Management System

Cellnovo Launches World First Mobile-Connected Diabetes Management System

Having received European CE Mark approval in September, Cellnovo out of London, UK has launched its diabetes management system that looks like a smartphone system, but is actually an integrated glucometer, wirelessly connected insulin pump, activity monitor, and cell phone-based data transfer system to share readings with family and clinicians.cellnovo-diabetes-management-system

To kick off the release of the system, Cellnovo launched a usability trial involving type 1 diabetics whose doctors will be able to monitor their blood glucose levels in real time as they’re being measured.

Co-trialist, Dr Mark Evans of Addenbrookes Hospital in Cambridge, commented, “This technology represents a entirely new model for the management of diabetes and one that could be of direct and long-term financial benefit to the NHS. The effective management of diabetes requires masses of information. The more information we have, and the more rapidly we have it, the better job we can do of using our resources efficiently to prevent the devastating long-term complications of diabetes. The Cellnovo system is the world’s first both to automate and deliver instantly the information we need – a task achieved through the thoughtful and thorough integration of consumer technology, such as wireless and cellular, with medical sensor and precision pump technologies.”

Co-trialist, Professor Stephen Greene of the University of Dundee added, “The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen. With accurate and current information we can identify and address problems immediately that, otherwise, might go unnoticed for months, contributing to excess cost and potentially tragic patient complications. In this clinical trial we will be the first to explore these new opportunities in diabetes patient management and hope to uncover new ways to improve and extend care, optimise workflow and drive cost efficiencies.”

Cellnovo’s diabetes management system comprises an insulin pump that connects wirelessly to an intuitive ‘app-based’ touch-screen handset. The handset features an integral blood glucose monitor, an activity monitor and a mobile (GSM) data connection to a comprehensive web-based clinical management system.
Cellnovo patients will be able to track and manage their diabetes; securely sharing all clinical information through the web so that they, their doctors, nurses and family members can ensure sustained and effective diabetic control.

Principal Investigator of the Cellnovo usability trial, and world-leading authority on insulin pump therapy, Professor John Pickup of King’s College London School of Medicine, remarked, “This clinical trial is not just the world’s first with a mobile-connected insulin infusion system, it is also the first clinical trial in which the care team and patients can simultaneously observe and evaluate patient data in real-time, anywhere in the world.”

Co-trialist, Dr Mark Evans of Addenbrookes Hospital in Cambridge, commented, “This technology represents a entirely new model for the management of diabetes and one that could be of direct and long-term financial benefit to the NHS. The effective management of diabetes requires masses of information. The more information we have, and the more rapidly we have it, the better job we can do of using our resources efficiently to prevent the devastating long-term complications of diabetes. The Cellnovo system is the world’s first both to automate and deliver instantly the information we need – a task achieved through the thoughtful and thorough integration of consumer technology, such as wireless and cellular, with medical sensor and precision pump technologies.”

Co-trialist, Professor Stephen Greene of the University of Dundee added, “The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen. With accurate and current information we can identify and address problems immediately that, otherwise, might go unnoticed for months, contributing to excess cost and potentially tragic patient complications. In this clinical trial we will be the first to explore these new opportunities in diabetes patient management and hope to uncover new ways to improve and extend care, optimise workflow and drive cost efficiencies.”

William F. McKeon, Cellnovo Chief Executive Officer added, “The launch of the Cellnovo system marks a new era in medicine where mobile connectivity is routinely embedded in medical devices. We draw upon the convenience of mobile technology in so many aspects of our lives: email, photos, social networking and banking. It is now time that our most precious asset, our health, benefits from the real-time information flow that is made possible with an in-built mobile connection. We are moving into an era where our doctors will routinely detect health issues over the web, before they worsen; and where patients and family members have the peace of mind that dangerous and costly emergencies can be avoided as early signs are immediately spotted.”

“The Cellnovo usability trial will be conducted in ten of the leading diabetes centers across the UK and will involve 100 patients, both adults and children. Such scale is unprecedented for a trial of insulin infusion technology and its usability.” concluded Dr Reman McDonagh, Director of Clinical and Physician Relations for Cellnovo.

Type 1 diabetes is routinely managed with pump technology throughout much of Europe and North America where 20-25% of patients gain benefit from therapy that mimics the body’s normal production of insulin. Yet the UK lags behind, with 96% of patients having to rely on multiple daily injections. By introducing a unique system that uses cellular data and touch screen technology, Cellnovo aims to eliminate the barriers to adoption of insulin pump therapy; simplifying and reducing the workload for doctors and nurses, while also improving the quality of insight and diabetes management achieved by patients.

Type 1 diabetes affects 250,000 UK patients for whom the prospect of poor diabetic control can lead to blindness, nerve damage and death. Caring for diabetes accounts for 10% of the NHS budget, a significant proportion of which is focused on type 1, a growing challenge that affects 4% more UK patients each year. Type 1 diabetes can only be managed by the daily or constant administration of insulin, replacing the role of the pancreas that for these patients has become incapable of producing insulin, which is vital for the metabolism of carbohydrates.

Source:https://www.pressdispensary.co.uk/releases/c993326.html

Full story

Boston Scientific Launches Innovative Crossing Device to Treat Complete Blockages in Peripheral Arteries

Boston Scientific Launches Innovative Crossing Device to Treat Complete Blockages in Peripheral Arteries

Boston Scientific has launched its TruePath CTO Device in the U.S. with a rollout in Europe scheduled for later in the year.boston-scientific-truepath-details

penetrating through chronic total occlusions that block peripheral arteries, avoiding the need for the patient to undergo a bypass.

The device features a diamond coated tip that can spin at 13,000 rpm to drill right through uncooperative plaque buildups.

The TruePath CTO Device features a rotating diamond-coated tip designed to break through occluded peripheral arteries and facilitate the placement of conventional guidewires for treatment of peripheral lesions.  The ultra-low 0.018″ profile is roughly half the size of competitive devices and is engineered for optimal crossing.  Once positioned, the distal tip rotates at 13,000 rpm to facilitate drilling through calcified lesions and other fibrous blockages.  The TruePath device requires no capital equipment and is available with an optional extension wire to facilitate catheter exchange and increase the working length beyond 300 cm.

The ReOpen clinical study evaluated the TruePath CTO Device in 85 patients with peripheral artery lesions.  Study results demonstrated the device is safe and effective in facilitating the crossing of intraluminal CTOs following resistance or prior failed attempts with a conventional guidewire.  In the study, technical success (defined as facilitation of CTO crossing) was achieved in 80.0 percent of patients, while improved post-procedure blood flow was demonstrated in 82.4 percent of patients.  Safety was demonstrated with a 98.8 percent freedom from clinical perforation at the time of procedure.

NATICK, Mass., Feb. 8, 2012 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announces the U.S. launch of the TruePath™ CTO Device, designed to facilitate the crossing of chronic total occlusions (CTOs, or complete blockages) within the peripheral vasculature.  The Company will begin marketing the product immediately in the U.S. and expects to launch the product in Europe and other international markets in the first half of 2012.

CTOs, which represent complete artery blockages, are extremely difficult to treat with standard endovascular devices such as guidewires and other catheter-based technologies.  CTO devices permit endovascular treatment in cases that otherwise might require a patient to undergo bypass surgery or risk lower extremity amputation.

“CTOs are very challenging, requiring additional time, resources and patient exposure to imaging contrast and radiation,” said J. A. Mustapha, M.D., Director of Endovascular Intervention at Metro Health Hospital in Wyoming, MI.  “The TruePath device is an exciting new technology that allows me to effectively penetrate these difficult blockages with greater speed and ease, allowing access to untreated lesions and helping to improve overall patient outcomes.”

The TruePath CTO Device features a rotating diamond-coated tip designed to break through occluded peripheral arteries and facilitate the placement of conventional guidewires for treatment of peripheral lesions.  The ultra-low 0.018″ profile is roughly half the size of competitive devices and is engineered for optimal crossing.  Once positioned, the distal tip rotates at 13,000 rpm to facilitate drilling through calcified lesions and other fibrous blockages.  The TruePath device requires no capital equipment and is available with an optional extension wire to facilitate catheter exchange and increase the working length beyond 300 cm.

“The TruePath device is another example of innovation in our priority growth area targeting peripheral vascular disease, where a significant number of patients remain undiagnosed or untreated,” said Jeff Mirviss, President of the Boston Scientific Peripheral Interventions Division.  “This innovative crossing device further expands our growing peripheral interventions portfolio and offers physicians an option to treat patients with challenging lesions in the lower extremities who may have otherwise faced amputation.  Addressing this growing health problem through the use of less-invasive devices could greatly improve patient care and ultimately save limbs.”

The ReOpen clinical study evaluated the TruePath CTO Device in 85 patients with peripheral artery lesions.  Study results demonstrated the device is safe and effective in facilitating the crossing of intraluminal CTOs following resistance or prior failed attempts with a conventional guidewire.  In the study, technical success (defined as facilitation of CTO crossing) was achieved in 80.0 percent of patients, while improved post-procedure blood flow was demonstrated in 82.4 percent of patients.  Safety was demonstrated with a 98.8 percent freedom from clinical perforation at the time of procedure.

An estimated 17.6 million Americans and more than 30 million people worldwide suffer from peripheral vascular disease[1], which is characterized by blockages in vessels of the lower limbs and associated with high rates of morbidity and mortality.  CTOs are estimated to be present in approximately 40 percent of patients treated for symptomatic peripheral artery disease[2].

Boston Scientific acquired the TruePath technology through its acquisition of ReVascular Therapeutics, Inc. in February 2011.  The TruePath CTO Device has received 510(k) clearance from the U.S. Food and Drug Administration and carries CE Mark approval.

For more information on the TruePath CTO Device, visit Boston Scientific’s Peripheral Interventions website at:www.bostonscientific.com/peripheral-interventions.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that 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 our business plans, new product launches and launch cadence, regulatory approvals, clinical trials, product performance, clinical outcomes and competitive offerings.  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.

Source:http://bostonscientific.mediaroom.com/index.php?s=24889&item=121294

Full story

Kickstarter project

Kickstarter project

SkyLight, a technology start-up which began life as a Kickstarter project, has announced the release of its namesake microscope-to-smartphone adapter this coming March. The minimalist SkyLight adapter can optically interface any smartphone device to any microscope via a series of simple sliding and locking fixtures, which help to position the smartphone’s camera over the microscope’s eyepiece lens.The adapter is made of lightweight plastics and weighs less than an iPhone.skylight

The project was the brainchild of Andy Miller, a designer and engineer who, as an undergraduate, developed low cost microscopes for the developing world. According to the company, the SkyLight adapter was designed as a simple way to remotely connect doctors to patients in rural locations using existing microscopes and easy to use, increasingly available smartphones.

The SkyLight is a smartphone-microscope camera adapter that stands to revolutionize telemedicine by bringing together two previously disparate but widely available technologies: smartphones and microscopes. Attaching a smartphone with the SkyLight instantly upgrades available microscopes of any age, allowing diagnostic images to be captured on camera and securely transmitted from anywhere around the world to a trained expert able to make that life-saving diagnosis.

Make science education exciting, intuitive, and sharable. The SkyLight allows equipment and the viewing experience to be shared by teachers and students of all ages. Even better, the resulting images and videos can be shared through social media among science and education communities, classrooms, friends, or even with the world.

Share exciting finds with co-workers, friends, and the online community! The SkyLight, a minimalist iPhone microscope adapter, holds any smartphone steady while taking photographs or videos, making it a perfect companion for researchers and adventurers alike. The SkyLight attaches to eyepieces of spotting scopes as well as microscopes, so weekend microscopists or bird watchers can record sightings, confirm species, or just remember those lifetime birds.

Full story

TearScience Achieves FDA Clearance for Second Generation LipiFlow® Thermal Pulsation System

TearScience Achieves FDA Clearance for Second Generation LipiFlow® Thermal Pulsation System

TearScience of Morrisville, NC received FDA clearance for the new version of the LipiFlow Thermal Pulsation System for evaporative dry eye. The condition leaves patients with too few tears, making the remaining ones feel too salty. The system heats and massages the eyelids, helping unblock the flow of lipids from the meibomian glands found under the eyelids.

The new generation of LipiFlow provides the ability to two treat both eyes simultaneously, cutting treatment time in half, to about 12 minutes. It also sports a new interface that displays treatment temperature, pressure sequence and treatment time remaining, while recording all the data for easy sharing with the clinic’s electronic medical record system.

MORRISVILLE, N.C.,— February 1, 2012—TearScience, Inc., a privately-held medical device company, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow® Thermal Pulsation System , a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids. The second generation product includes a more robust graphical user interface and provides the ability for physicians to treat both of a patient’s eyes simultaneously.

The new LipiFlow® console incorporates an enhanced graphical user interface by controlling pressure and displaying the treatment temperature, pressure sequence and treatment time remaining. The new LipiFlow® also allows physicians to store a record of the treatment on the device and on electronic medical record servers, eliminating the need to manually document the treatment in patient records.

LipiFlow®’s second generation product also allows physicians to treat two eyes simultaneously. Time savings achieved by performing a bilateral treatment is beneficial for both busy physicians and patients alike.

“We are pleased to have received FDA clearance for the second generation LipiFlow® to offer to our current and future customers,” said Tim Willis, chief executive officer and co-founder of TearScience. “The improvements in this next generation LipiFlow® reflect TearScience’s commitment to innovation. TearScience expects to provide many more enhancements that will assist physicians in treating dry eye sufferers efficiently, effectively and profitably.”

TearScience’s second generation LipiFlow® product will be commercially available in March 2012. Physicians currently using TearScience’s first generation LipiFlow® will be upgraded to the new system.

TearScience sells its LipiFlow® and LipiView® Ocular Surface Interferometer devices as a system for eye care practices. The LipiView® enables physicians to visualize the eye’s tear film. LipiView® won the 2011 Medical Design Excellence Award.

About TearScience, Inc.
Headquartered in Morrisville, North Carolina, TearScience has pioneered devices that provide significant clinical improvement in the treatment of evaporative dry eye. Of the more than 100 million dry eye sufferers worldwide, approximately 80 percent have evaporative dry eye, which is caused by meibomian gland dysfunction (MGD) and a lipid deficiency of the eye’s natural tear film. The Tear Film and Ocular Surface Society (TFOS) workshop, involving two years of work by 50 leading experts from around the world, concluded that MGD is an under-estimated condition and is very likely the most frequent cause of dry eye disease. Common symptoms of the disease include eye irritation, dryness, redness, tiredness, and visual disturbances. TearScience’s integrated, in-office system enables eye care professionals to effectively address a root cause of evaporative dry eye, obstructed meibomian glands.

Source:http://www.tearscience.com/en/tearscience-achieves-fda-clearance-for-second-generation-lipiflow-thermal-pulsation-system

Full story

Fantastic Voyage: GE Invests in Bowel Surfing Capsule that May Help Doctors Detect Colon Cancer

Fantastic Voyage: GE Invests in Bowel Surfing Capsule that May Help Doctors Detect Colon Cancer

GE has announced investing into an Israeli company called Check-Cap that’s developing swallowable endoscopic capsules for imaging the insides of the GI tract.  Check-Cap seems to be a direct competitor of the better known Given Imaging, also an Israeli firm, that’s been producing its own PillCams for visualizing everything from the esophagus to the small intestine and beyond.

While PillCams use light in the visible spectrum and a traditional image sensor, the Check-Cap delivers low energy X-rays that provide a much different look at the internal anatomy.  Because X-rays penetrate through soft material, food intake shouldn’t be a problem for the device, and all the typical preparation for a GI tract analysis may not have to apply.

From the announcement:

The device, which employs low energy X-ray-based technology to safely generate high resolution 3D imagery, may help doctors detect colorectal cancer. No cleansing involved. The capsule continuously transmits information to a wrist-worn data receiver. Patients can go play a round of golf or take a walk while the tiny device does its work. At the end of the journey, the capsule leaves the body the “natural” way.

GE Healthcare and Check-Cap will also design and manufacture miniature cadmium zinctelluride (CZT) diagnostic imaging sensors placed inside each Check-Cap capsule. The sensors will give clinicians a full 360-degree view as the capsule moves through the colon. GE Healthcare has many years of experience in developing CZT-based detectors. Similar technologies have been used in the company’s nuclear medicine and bone densitometry systems.

Check-Cap plans to introduce its capsule in the European Union in late 2013, subject to regulatory approval. The company is also in discussions with the U. S. Food & Drug Administration (FDA).

Check-Cap designed an ingestible capsule that snaps pictures as it travels through the bowels. The device, which employs low energy X-ray-based technology to safely generate high resolution 3D imagery, may help doctors detect colorectal cancer. No cleansing involved. The capsule continuously transmits information to a wrist-worn data receiver. Patients can go play a round of golf or take a walk while the tiny device does its work. At the end of the journey, the capsule leaves the body the “natural” way.

The $250 million healthymagination fund invests in promising healthcare technology companies. It has focused on diagnostics, medical information management technology, and life sciences.

GE Healthcare and Check-Cap will also design and manufacture miniature cadmium zinc telluride (CZT) diagnostic imaging sensors placed inside each Check-Cap capsule. The sensors will give clinicians a full 360-degree view as the capsule moves through the colon. GE Healthcare has many years of experience in developing CZT-based detectors. Similar technologies have been used in the company’s nuclear medicine and bone densitometry systems.

Colorectal cancer is the third most common cancer in men and the second in women, according to the International Agency for Research on Cancer. Almost 60 percent of the cases occur in developed regions. Globally, it is the fourth most common cause of death from cancer. About 608,000 deaths from colorectal cancer are estimated worldwide annually, accounting for 8 percent of all cancer deaths. In the United States, colorectal cancer is the second leading cause of death from cancer.

Check-Cap plans to introduce its capsule in the European Union in late 2013, subject to regulatory approval. The company is also in discussions with the U. S. Food & Drug Administration (FDA).

Source:http://www.gereports.com/fantastic-voyage/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+gereports%2Ffeed+%28GE+Reports%29&utm_content=Google+Reader

Full story

InterVapor Endoscopic Thermal Ablative Treatment for Emphysema Gets CE Mark

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series C funding round, which will support commercialization of InterVapor for treatment of severe emphysema. This news comes on the heels of Uptake Medical receiving CE mark approval for InterVapor in September, completing the first commercial use of InterVapor in Germany in November, and recently announcing TGA approval for InterVapor to be marketed in Australia.

Steven Kesten, Chief Medical Officer at Uptake Medical, answered our questions about the company and its technology:

1.   How did the idea of InterVapor come about?

The idea for Uptake Medical’s InterVapor™ technology was based on the body’s healing response to thermal energy. Early research was based on the hypothesis that if we were able to trigger a temporary Localized Inflammatory Response (LIR) that the associated healing process would ultimately develop a scar that would remodel and reduce the diseased lung tissue. Early experiments were conducted using various forms of heat energy, such as radio frequency, but the energy could not travel out to the diseased areas of the lung due to a lack of available lung mass. Experimentation ultimately lead to the discovery that heated water vapor (steam) was the optimal form of heat energy as it is in gas form and could easily travel through the airways to the diseased parenchyma. The development team made a prototype, proved the theory with ex-vivo animal lungs and this is the basic theory which has been ultimately proven in both animal and human clinical studies.

2.   Can you describe the process of delivering the heated vapor to the diseased lung?

In advance of the InterVapor procedure, a personalized treatment plan is developed specifically for the patient to be treated. A high-resolution CT of the patient’s lungs is analyzed by the Uptake Medical core lab. This analysis includes a quantitative assessment of several factors to determine the degree of heterogeneity and to identify the lung regions where the best opportunity for lung volume reduction may be successfully achieved. These recommendations are forwarded to the treating pulmonologist as an InterVapor Personalized Procedure Program™ (IP3™).

For the procedure itself, a bronchoscope is inserted into the lungs and the physician, following the blue print provided by the IP3, reviews the patient’s lungs and determines the course of treatment. The InterVapor Catheter is inserted through the working channel of the bronchoscope into the targeted airway. The treatment time specific to the target airway is obtained from the IP3 and keyed into the InterVapor Generator. This airway is briefly occluded by the inflation of a balloon at the end of a catheter and a dose of heated water vapor is delivered to the lung tissue. The balloon is then deflated, the catheter is removed and additional airways are treated as appropriate. The entire procedure, on average, takes 30 minutes.

InterVapor Mechanism of Action:

Treatment: The delivery of heated water vapor triggers a temporary Localized Inflammatory Response (LIR) which sets the body’s natural healing process in motion.

Healing: This LIR is usually resolved within 4-12 weeks as the lung begins the healing and remodeling process.

Response: InterVapor has been shown to lead to clinical improvements in lung function, exercise capacity and health-related quality of life.

3.   What meaningful clinical improvement above and beyond medical therapy can we expect with InterVapor, especially in terms of exercise function and quality-of-life?

In the VAPOR trial patients received optimal medical management prior to treatment with InterVapor. InterVapor therapy resulted in clinically relevant improvements in lung function, quality of life and exercise tolerance in upper lobe predominant emphysema. At 6 months, airflow as assessed by FEV1, FEV1 improved by 141 ml, air trapping as assessed by residual volume (RV) was reduced by 406ml. Health-related quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ) total score improved by 14.0 units with a 4 unit improvement having been reported as the minimal clinically important difference. Exercise capacity, as assessed by the 6-minute walk test, improved by 46.5 m and breathlessness, as measured by the modified Medical Research Council (mMRC) dyspnea scale improved by 0.9 units. All of the above endpoints were associated with p values less than 0.05. The results were clinically and statistically significant.

The results of the VAPOR trial are available online, ahead of publication, in the European Respiratory Journal. (Snell, G., et al. Bronchoscopic Thermal Vapor Ablation Therapy in the Management of Heterogeneous Emphysema. Eur Respir J 2012; DOI 10.1183/09031936.00092411)

4.   Is this a one-time procedure or can this be repeated multiple times to different diseases segments of the lungs?

The InterVapor System is intended for use in patients with heterogeneous severe emphysema to achieve bronchoscopic upper lobe lung volume reduction by the application of heated water vapor to the lung segments targeted for treatment. The clinical results observed in the VAPOR trial were achieved as a single, unilateral procedure. In a typical InterVapor treatment, 3-8 airways within a lung are treated.

5.   Where is InterVapor therapy currently available? Is it available in any capacity in the United States?

Uptake Medical has received the CE mark and TGA approval for InterVapor and we are focusing our commercial efforts in both Germany and Australia at this time. We plan to extend our commercialization throughout Europe during 2012. At this time InterVapor is not available in the US.

Full story

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability.

The company already has approval from the FDA to market the Cardius X-ACT in the U.S.

POWAY, CA – (MARKET WIRE) – 01/25/12 – Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union. The Cardius X-ACT imaging system was designed to increase diagnostic accuracy and make earlier detection of disease possible.

Digirad also announced that it had begun to strategically build out a targeted international selling network by signing a distribution agreement with Epsilon Elektronik in Turkey, a part of the Istanbul-basedBozlu Group. Last year, Digirad signed a similar agreement with UK-based Southern Scientific, which has already placed an ergo™ portable solid-state camera at the Manchester Royal Infirmary where it is being used in a number of general and surgical imaging settings.

“One of the legs of our transition to growth in the product category is to build a targeted network of top distributors in key international markets that have a growing demand for flexible, high-quality imaging products such as the X-ACT. Our experience and the data indicate that price point, flexibility and potential for better clinical outcomes at lower overall costs are key elements to healthcare buying decisions, and our growing line of camera products uniquely fits those requirements,” said Digirad CEO Todd P. Clyde. “It is our intention, as one of several new initiatives in 2012, to more aggressively build a distribution network to tap the developing markets for dedicated cardiac and portable nuclear imaging in a more meaningful way. To that end, gaining of CE Mark and additional distribution agreements are key initial elements of that process.”

The Cardius X-ACT imaging system features a low-dose volume-computed tomography attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues.

“We believe our Cardius X-ACT imaging system, our ergo flexible imaging camera and future camera models will be well-received internationally because of their accuracy, diagnostic benefits and economic models that fit well with healthcare spending. They all provide new clinical information that increases the benefit of nuclear cardiology procedures. That increase in diagnostic confidence can improve outcomes and raise the standard in the industry internationally for SPECT system performance at a price point that is accessible in many countries,” added Clyde.

Digirad has previously received clearance from the FDA to market the Cardius X-ACT imaging system in the U.S. and has garnered both CE Mark and FDA clearance to market its ergo portable solid-state camera.

About Digirad Corporation
Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit www.digirad.com. Digirad® and Cardius® are registered trademarks of Digirad Corporation.

Source:http://drad.client.shareholder.com/releasedetail.cfm?ReleaseID=642105

Related Posts Plugin for WordPress, Blogger...

Full story

Page 1 of 41234
Copyright © 2017 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes