The U.S. Food and Drug Administration (FDA) has approved the Covidien's EverFlex Self-Expanding Peripheral Stent System for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA).
The EverFlex System is now available in the US, including a 200mm stent length.
The FDA approval was supported by the Durability II Investigational Device Exemption trial that enrolled patients at clinical sites within the US and Europe.
The clinical study evaluated lesions up to 18 cm and specifically tested the performance of a single long, up to 200mm stent, in the SFA and PPA.
Results from the study show no major adverse events at 30 days and a low one-year stent fracture rate of 0.4%.
The company claims that one long stent placement instead of multiple shorter stents may lead to better long term clinical performance.
Covidien Chief Medical Officer of Vascular Therapies Mark Turco said the Durability II findings demonstrate the safety and effectiveness of EverFlex stents.
"Having an indication in the SFA – as well as a 200 mm stent – is imperative when treating Peripheral Arterial Disease (PAD)," Turco added.