Panel to review Xience DES and Thoratec's HeartMate II

p>The FDA's circulatory systems device panel will review the Xience V DES from Abbott Vascular (Santa Clara, California) on Nov. 29, the first day of a two-day meeting by the panel. On Nov. 30 the panel will review the HeartMate II, a second-generation ventricular assist device from Thoratec (Pleasanton, California).

Abbott said that the application for Xience V is the first to include data demonstrating superiority of one DES over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product.

Assuming approval, the company anticipates U.S. market roll-out in the first half of next year

Thoratec describes the HeartMate II as a "smaller, more durable version of the original, battery-powered Heart Mate.