The federal Food and Drug Administration has approved a continuous-flow heart-assist device pioneered at the Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) for use as a permanent treatment for advanced heart failure. The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major milestone for patients in the United States.

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“Nanoburrs” are nanoparticles coated with a sticky protein that makes them cling onto artery walls while they slowly release drugs: the US researchers who are developing them hope they will one day provide an alternative to drug-releasing stents in fighting heart disease. The Massachusetts Institute of Technology, (MIT) and Harvard Medical School researchers, wrote about how they developed and tested the nanoburrs as potential drug-releasing agents for targeting and repairing damaged blood vessels.

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Abbott announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V (R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.

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Medtronic Inc has confirmed that it had received a warning letter from U.S. health regulators calling for corrective actions based on an inspection of its Mounds View, Minnesota, facility, the headquarters of its cardiac rhythm management (CRM) business, the company’s largest unit. The letter from the Food and Drug Administration comes in the wake of problems Medtronic has had with its leads that are used with implantable cardioverter defibrillators, known as ICDs.

Boston Scientific Corporation has announced that it has received CE Mark for its PROMUS® Element(TM) Everolimus-Eluting Coronary Stent System, the Company’s third-generation drug-eluting stent (DES) technology. The PROMUS Element system incorporates a unique platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. The Company will begin marketing the PROMUS Element system immediately in the European Union and other CE Mark countries.

Onset Medical Corporation has announced that it has received U.S. FDA 510(k) marketing clearance for the Company’s SoloPath™ TransFemoral Endovascular Access Catheter. These catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices. Another clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treating aortic aneurysms.

Boston Scientific Corp has received approval from the FDA to market its new WallFlex Biliary RX covered stents. The stents are designed to treat clogged bile ducts in cancer patients. The liver excretes bile, which the body uses to help digest food. The WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006. The new covered version of the stents was also approved by European regulators.

The FDA announced that roughly 5,400 HeartStart FR2+ automated external defibrillators made by Philips have been recalled because they may carry a defective memory chip that can render the life-saving devices inoperable. Although there have been reports of the memory chips in some of the defibrillators failing during routine self tests, none of them have failed during emergencies and caused patient injuries or deaths.

The Johnson & Johnson subsidiary, Cordis, wins a nod from the FDA for its 2.25mm Cypher drug-eluting stent for treating blockages in small blood vessels. The company said data from the RESEARCH and T-SEARCH studies indicated that patients treated with the small Cypher model had a 65% lower incidence of death or heart attack than patients treated with the 2.25mm Boston Scientific device.

Zoll Medical Corp received the FDA marketing approval for a new model of its LifeVest wearable defibrillator. The LifeVest is worn by patients who are at a risk of sudden cardiac arrest. Zoll said more than 2,000 patients are currently using the product. The company aims to increase its inventory to support further growth.