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FDA Approves S.M.A.R.T. Vascular Stent for Peripheral Indications
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Cordis Corp. has announced the FDA approval of its S.M.A.R.T. Control Vascular Stent System for use in the superficial femoral artery and/or the proximal popliteal artery, making it the first stent in the United States available for use in both indications.
The approval was supported by data from the STROLL investigational device exemption trial, which enrolled 250 patients at 39 clinical sites in the United States. According to a press release, at 1 year, freedom from clinically driven target lesion revascularization was 87.4% and the primary patency rate was 81.7%, and there were no major adverse events at 30 days. Also, the 1-year stent fracture rate was 2% and only type 1 stent fractures were observed.
In addition, health-related quality-of-life surveys also showed an improvement in patient outcomes with the stent, including minimal or no signs of peripheral arterial disease in three of four patients and normal ankle brachial index in four of five patients at 1 year, according to the release.
Perspective
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Robert S. Dieter, MD, RVT
Despite the long history of using peripheral vascular products 'off-label,' there has been an ever-increasing interest in developing FDA-approved indications and 'on-label' use of products. With that in mind, it is exciting that Cordis Corp. has gained FDA approval for the use of its S.M.A.R.T. stent in the superficial femoral artery and the popliteal artery. Although it has been indicated outside the United States since 1999 for this indication, it now represents the first stent in the United States to have an iliac, superficial femoral artery and popliteal artery indication. This continues to mark a trend in gaining FDA approval for vascular-bed-specific use of peripheral stents.
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