Cordis Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved the 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 Unites States 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. In the study, freedom from clinically driven target lesion revascularization (TLR) at one year was 87.4%. The 12-month primary patency rate for the S.M.A.R.T.® Stent was 81.7% by Kaplan Meier estimate. The study results show no major adverse events at 30 days and a low one-year stent fracture rate of 2.0 percent. In addition, all stent fractures were Type I, least severe, and there were no incidents of more severe stent fractures (Type II-V).
"The STROLL trial demonstrates one year patency rates of ~81% and a very low fracture rate,” said Dr. William A. Gray, Director of Endovascular Services, Cardiovascular Research Foundation, New York, and co-national principal investigator of the STROLL study. “These outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery."
In addition to the excellent clinical outcomes in the STROLL study, Health Related Quality of Life (QOL) Surveys also showed an improvement in patient outcomes. This included minimal or no signs of PAD* in 3 of 4 patients (as measured using Rutherford-Becker classification), and normal Ankle Brachial Index (ABI) in 4 of 5 patients at 1 year.
“We are very pleased to offer an expanded indication for the S.M.A.R.T.® Stent,” said Shlomi Nachman, Worldwide President, Cordis Corporation. “Our goal is to continue to make expanded indications and new products available to our customers so they may bring these innovations to their patients.”