FDA approves Covidien's EverFlex Self-Expanding Peripheral Stent System

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. 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, which has been approved for peripheral indication in international markets since 2006, 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 Investigational Device Exemption trial that enrolled patients at clinical sites within the U.S. and Europe. DURABILITY II is the first clinical study to evaluate lesions up to 18 cm and to specifically test the performance of a single long, up to 200 mm stent, in the SFA and PPA. Specifically, the study results show no major adverse events at 30 days and a low one-year stent fracture rate of 0.4 percent. Additionally, primary patency at one year was 67.7 percent when analyzed by simple proportions of patients patent; using Kaplan-Meier time-to-event analysis, it was 77.2 percent.

"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. 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," said Dr. Krishna Rocha-Singh, MD, Director, Prairie Vascular Institute, Springfield, Illinois, and co-national principal investigator of DURABILITY II.

Until now, physicians often addressed longer lesions by overlapping multiple stents. Overlapping stents have a higher propensity to fracture, thereby increasing the potential for restenosis to occur. Being able to place one long stent, versus multiple shorter stents, may lead to better long term clinical performance.

"The DURABILITY II findings demonstrate the safety and effectiveness of our EverFlex stents," said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. "Having an indication in the SFA - as well as a 200 mm stent - is imperative when treating Peripheral Arterial Disease (P.A.D.)."