A Medical Device Daily

Abbott (Abbott Park, Illinois) said that the FDA has confirmed a circulatory systems devices advisory panel meeting on Nov. 29 to review the company’s premarket approval (PMA) submission for the XIENCE V everolimus eluting coronary stent system.

Abbott filed its PMA for XIENCE V with the FDA on June 1, 2007. The company anticipates that it will launch XIENCE V in the U.S. in the first half of 2008, pending FDA approval.

The PMA for XIENCE V is the first to include data demonstrating superiority of one drug eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product. Additionally, XIENCE V showed clinical superiority in the safety and efficacy endpoint of major adverse cardiac events (MACE). MACE is an important measure of clinical outcomes for patients, and is defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR associated with symptoms or documented lack of blood supply).

• The FDA also reported that its outside experts will meet on Nov. 30 to consider approving the HeartMate II mechanical heart device from Thoratec (Pleasanton, California).

The device is a smaller, more durable version of the original, battery-powered Heartmate, which is surgically implanted in the chest and helps the lower left heart chamber pump blood throughout the body.