FDA clears Covidien's peripheral stent

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The 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 U.S. The device includes 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 in the U.S. and Europe. DURABILITY II sought 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.