Archive for June, 2010

FDA Looking Into Heart-Related Death Risk of Benicar

The FDA is looking into whether Daiichi Sankyo’s blood pressure medicine Benicar increases the risk of heart-related death. The regulatory body said it is evaluating data from a pair of clinical trials in which diabetes patients taking the drug, known chemically as olmesartan, had a higher rate of death from heart related causes compared with patients taking a placebo. In addition to reviewing data from the two studies, the FDA said it is considering additional ways to assess the cardiovascular effects of Benicar.

FDA okays expanded offering of Powerlink stent graft products

Endologix Inc, a medical device maker, said it has received approval from the US regulatory authority to market an expanded offering of its Powerlink stent graft products. Powerlink, which is an already approved endovascular stent graft, is used in the treatment of abdominal aortic aneurysm. In abdominal aortic aneurysm, the aortic wall weakens, creating a “ballooning” of the blood vessel.

Boston Scientific Launches Platinum Chromium TAXUS(R) Element(TM) Stent System

Boston ScientificBoston Scientific Corporation has announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included an indication for the treatment of diabetic patients.

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