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Market & Industry Briefs

Brief summaries of recent medtech market and industry developments. This month we cover FDA's approval of Thoratec's HeartMate II VAD, the settlement of Boston Scentific and J&J's patent suits, a German appeals court's favorable ruling on Corevalve's transcatheter aortic heart valve system and the Obama administrations budget request for a national device registry.

Thoratec Corp. received US Food and Drug Administration (FDA) approval late in January for an expanded indication for the HeartMate II left ventricular assist system (VAD), enabling the device to be marketed for destination therapy (DT) in patients with advanced-stage (New York Heart Association Class IIIB or IV) heart failure who have been on optimal medical therapy for at least 45 of the past 60 days and are not eligible for transplantation. As a condition of approval, the company will conduct a postmarket study of 247 patients who will be followed for up to two years.

The HeartMate II is a continuous-flow VAD that is smaller and simpler in design (and more durable and less fraught with complications) than the company's older generation pulsatile HeartMate XVE....

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