FDA Approves Covidien's EverFlex Stent System for SFA/PPA Use

March 7, 2012—Covidien (Mansfield, MA) announced that the US Food and Drug Administration (FDA) has approved the EverFlex self-expanding peripheral stent system for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA). The EverFlex system has been approved with a peripheral indication in international markets since 2006. It is now available in the United States, including a 200-mm stent length.

The clinical data supporting the FDA approval of the EverFlex system for use in the peripheral vasculature was obtained through the DURABILITY II trial that enrolled patients at clinical sites within the United States and Europe. DURABILITY II evaluated lesions up to 18 cm and tested the performance of a single long stent (up to 200 mm) in the SFA and PPA.

Covidien reported that the study results showed no major adverse events at 30 days, and a 1-year stent fracture rate of 0.4%. Additionally, the primary patency rate at 1 year was 67.7% when analyzed by simple proportions of patients patent; using Kaplan-Meier time-to-event analysis, it was 77.2%.

"DURABILITY II is a landmark trial intended to study the patency and fracture resistance of placing a single nitinol stent in the superficial femoral artery," commented Krishna Rocha-Singh, MD, Co-National Principal Investigator of DURABILITY II. "It provided the clinical evidence necessary to demonstrate that you can successfully treat long, complex lesions in the SFA with the EverFlex self-expanding peripheral stent."