A Medical Device Daily
Medtronic (Minneapolis), which previously reported the decision by the FDA for its circulatory systems advisory panel to review the premarket application of its Endeavor stent in October (Medical Device Daily, Aug. 22, 2007), said that the panel meeting is set for Oct. 10.
The PMA proposal includes data “from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent [DES],” Medtronic says. In July, Medtronic said that the study reached its primary endpoints of target vessel failure (a composite of cardiac death, myocardial infarction and target vessel revascularization) at nine months (MDD, July 3, 2007).
Medtronic will present data on more than 4,100 patients who have been treated with the Endeavor stent in clinical trials that include follow-up for as long as four years; 675 of these followed for three years and more; and 1,287 followed for two years or more.
In related news, the FDA also told Abbott Laboratories (Abbott Park, Illinois) that it plans to schedule a panel review for the Xience drug-coated stent that Abbott hopes to bring to the U.S.
The Xience SPIRIT trial reached the primary endpoint of reducing vessel re-narrowing (angiographic late loss). Abbott submitted its final module for PMA review in June (MDD, June 4, 2007). CFO Thomas Freyman said the company is working with the FDA to schedule the meeting “as expeditiously as possible.”