The FDA issued approval for Covidien‘s EverFlex Self-Expanding Peripheral Stent System for implantation in the superficial femoral artery and/or the proximal popliteal artery.
The device, which is available in lengths up to 200 mm, has been available internationally since 2006.
Here’s more from the announcement about the clinical results that led to the approval:
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.
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.
Product page: EverFlex Self-Expanding Peripheral Stent System