The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways. The agency approved revised labeling for Edwards Lifesciences' Sapien heart valve...
FDA Approves Medtronic's Complete 'SE' Vascular Stent for Use in Superficial Femoral and Proximal Popliteal (Leg) ArteriesSeptember 24, 2013 11:42 am | by The Associated Press | News | Comments
Expanding its role in the treatment of peripheral artery disease in the United States, Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent for use in the lower extremities -- specifically, the superficial femoral artery (SFA) and proximal popliteal artery (PPA), which carry blood through the upper legs.
The threat from a heart attack doesn't end with the event itself. Blockage of blood flow to the heart can cause irreversible cell death and scarring. With transplants scarce, half the people who live through a heart attack die within five years. Scientists are trying to address this problem by engineering cardiac tissue to patch up damaged areas.
In patients with an acute heart attack, remote ischemic conditioning – intermittent inflation of a blood pressure cuff to cut off blood flow to the arm during transportation to hospital for acute balloon dilatation – reduces subsequent cardiac symptoms and mortality after acute heart attack.
A team from the University of Texas at Arlington has used mathematical modeling to develop a computer simulation they hope will one day improve the treatment of dangerous reactions to medical implants such as stents, catheters and artificial joints.
Pacemakers, insulin pumps, defibrillators and other implantable medical devices often have wireless capabilities that allow emergency workers to monitor patients. But these devices have a potential downside: They can be hacked. Researchers at Rice University have come up with a secure way to dramatically cut the risk that an implanted medical device could be altered remotely without authorization.
Seven out of 9 hospitals and healthcare providers surveyed "strongly" agreed that medical device makers need to step up their cybersecurity and privacy practices, according to a study conducted by the Deloitte Center for Health Solutions.
In the field of medical technology, wireless devices are seeing some of the most broad-reaching growth. This is due mostly in part to the wide range of applications that wireless medicine encompasses. Mobi Health News reports that the top ten areas wireless medicine has directly benefited include: Alzheimer’s, asthma, breast cancer, COPD, depression, diabetes, heart failure, hypertension, obesity, and sleep disorders.
Hospitals in 2011 paid an average of 34% less for drug-eluting stents than they did in 2007, according to a new report. They also paid 27% less for bare metal stents and 26% less for both pacemakers and cardiac resynchronization therapy defibrillators.
Medtronic, Inc. has announced clinical trial results showing that heart failure patients treated with its exclusive AdaptivCRT feature experienced a nearly 50 percent reduction in atrial fibrillation (AF) risk. Pioneered by Medtronic, the AdaptivCRT technology is a feature on certain cardiac resynchronization therapy-defibrillators...
The medical device and diagnostics market is set to grow at 4.5 percent per year (CAGR) between 2012 and 2018, totalling $455 billion in 2018, according to the newly-released EvaluateMedTech World Preview 2013, Outlook to 2018: The Future of Medtech report from market intelligence firm Evaluate Ltd.
Vascular Dynamics, Inc. Initiates "First in Human" Clinical Study of Its MobiusHDTM Device for the Treatment of Drug Resistant HypertensionSeptember 23, 2013 8:31 am | by The Associated Press | News | Comments
Vascular Dynamics, Inc. (VDI) announced today the first patient has been treated with the MobiusHD device; a catheter-delivered implant designed for the treatment of drug resistant hypertension. Dr. Chandan Devireddy of Emory University School of Medicine treated the first patient in the FDA-approved CALM-FIM_US Study.
Researchers at the University of Leicester and Glenfield Hospital have successfully used a novel “paper-clip” sized vascular coupling device to tackle resistant high blood pressure. The operation was carried out on Monday 16 September at Glenfield Hospital by Professor André Ng, Professor of Cardiac Electrophysiology at the University of Leicester and Consultant Cardiologist at Glenfield Hospital.
Researchers at MIT have developed a microfluidic device that mimics the flow of cancer cells through a system of blood vessels. Using high-resolution time-lapse imaging, the researchers captured the moments as a cancer cell squeezes its way through a blood vessel wall into the surrounding extracellular matrix.
With a few flicks of a light switch--on-off-on-off--Stanford University's Oscar Abilez is one step closer to changing the lives of millions. Why? Because as a focused speck of light turns on and off in Abilez's lab, a cluster of heart cells begins to expand and contract. He demonstrates that he can control the rhythm of a heart using just light.
Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.
Teleflex Launches ARROW JACC with Chlorag+ard Technology, the First and Only Long-Term Antimicrobial and Antithrombogenic CVCSeptember 19, 2013 5:00 pm | by Business Wire | News | Comments
Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced the launch of the new ARROW ® JACC with Chlorag + ard ® Technology. The ARROW ® JACC (Jugular Axillo-subclavian Central Catheter) with Chlorag + ard ® Technology is a small-french size antimicrobial and antithrombogenic catheter that is designed for both acute and long-term use.
The WaveCrest LAA Occluder is an implantable device that seals off the LAA opening so clots cannot escape into the blood stream and cause a stroke. It is a one-time treatment option for patients who would otherwise be on a lifetime regimen of anticoagulation therapy.
Coherex Medical Inc. announced it has received CE Mark approval for its Coherex WaveCrest LAA Occlusion System. Atrial fibrillation (AF) is the most common cardiac arrhythmia in today’s aging population, effecting nearly 6 million individuals in the US alone.
The CE marked TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during Transcatheter Aortic Valve Replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports.
Medical device maker Boston Scientific (NYSE:BSX) issued new warnings on its Cognis and Teligen implantable cardioverter defibrillators, advising physicians to watch out for premature battery depletion in older models. The problematic implants are no longer available and haven't been manufactured since December 2009...
Todd Dunlap, 62, arrived at Ronald Reagan UCLA Medical Center's emergency room on Aug. 8 suffering from shortness of breath, fatigue and extreme cold. When a CT scan revealed a 24-inch clot stretching from his legs into his heart, doctors feared the mass could break loose and lodge in his lungs, blocking oxygen and killing him instantly.
Boston Scientific agreed to pay an undisclosed amount to put its long-running patent war with OrbusNeich Medical to rest. The settlement covers patent infringement cases over coronary stent technology in the U.S., the U.K., Germany and Holland, according to an OrbusNeich press release.
The National Institutes of Health has awarded Georgia Tech a $2-million research grant to unravel the mechanical forces at play in lymphedema, a poorly understood disease with no cure and little hope for sufferers. Lymphedema develops when the body fails to circulate lymphatic fluid, a mixture of immune cells, proteins, and lipids.
Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced the PRECISION Registry, an ongoing study aimed at collecting data on the patterns of use, safety and effectiveness in the delivery and manipulation of percutaneous coronary intervention (PCI) devices.