The Food and Drug Administration has approved Medtronic Inc’s heart valve that can be implanted without open-heart surgery. Known as the Melody transcatheter pulmonary valve, the device is designed to be implanted through a small catheter inserted into the patient’s body. It replaces the pulmonary valve in patients born with a heart defect. It is the first heart valve approved for sale in the US that can be implanted without open-heart surgery.

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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A novel molecular imaging technology aimed at rapid diagnosis of cell death in organs such as the brain and heart has been licensed by The Medical College of Wisconsin to GE Healthcare. Under the license GE will further evaluate and develop the technology and will have an option to commercialize the technology. The technology, using imaging probes with a radiopharmaceutical compound, was invented by Ming Zhao, Ph.D., assistant professor of biophysics.

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Resverlogix Corp. has announced that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix’s oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD). The Cleveland Clinic has named this trial, ASSERT, which stands for ApoA1 Synthesis Stimulation Evaluation in Patients Requiring Treatment for Coronary Artery Disease.

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According to the findings of a recent study published in Journal of the American College of Cardiology, cardiovascular health of the obese can undergo a notable improvement if they lose some weight by eating less and undertaking more physical activity. The two-year study, conducted by researchers from Washington University School of Medicine in St Louis, found that weight loss in the obese improved some key measures of heart and vascular health.

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HeartWare International Inc. took another step in its chase after one-time suitor and main competitor Thoratec Corp. filing for an investigational device exemption from the Food & Drug Administration for clearance to use its miniature heart pump in patients with end-stage heart failure who aren’t eligible for a heart transplant. The Framingham, Mass.-based device maker’s left ventricular assist device is already cleared for use as a bridge to heart transplant.

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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.