FDA green-lights Cordis vascular stent for SFA, PPA

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The FDA has approved Cordis' S.M.A.R.T. Control vascular stent systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA).

The S.M.A.R.T. stent, which has been approved for peripheral indication in international markets since 1999, is now the first stent in the U.S. with both iliac and SFA indications. The clinical data supporting the FDA approval of the S.M.A.R.T. stent for use in the peripheral vasculature was obtained through the STROLL investigational device exemption (IDE) trial that enrolled 250 patients at 39 clinical sites within the U.S.