Cordis' SMART Stent Approved by FDA for Use in SFA

November 8, 2012—Cordis Corporation (Bridgewater, NJ) announced that the US Food and Drug Administration (FDA) approved the SMART Control vascular stent systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery. The SMART stent is already approved for iliac use in the United States, and it has been approved for peripheral indications in international markets since 1999, the company noted.

According to Cordis, the clinical data supporting the FDA approval of the SMART stent for use in the peripheral vasculature was obtained through the STROLL investigational device exemption trial, which enrolled 250 patients at 39 clinical sites in the United States.

William A. Gray, MD, Director of Endovascular Services at the Cardiovascular Research Foundation in New York City, served as co-national Principal Investigator of the STROLL study.

“The STROLL trial demonstrates 1-year patency rates of approximately 81% and a very low fracture rate,” Dr. Gray commented in Cordis' announcement. “These outcomes both meet and exceed our expectations for patients with symptomatic disease of the SFA."

At 1 year in the study, the SMART stent demonstrated a freedom from clinically driven target lesion revascularization of 87.4% and a primary patency rate of 81.7% by Kaplan Meier estimate. The study results showed no major adverse events at 30 days and a 1-year stent fracture rate of 2%. In addition, all stent fractures were Type I—there were no incidents of more severe stent fractures (Type II-V).

In addition to these clinical outcomes in the STROLL study, health-related quality-of-life surveys also showed an improvement in patient outcomes. This included minimal or no signs of peripheral arterial disease in 3 of 4 patients (as measured using Rutherford-Becker classification), and normal ankle brachial index in 4 of 5 patients at 1 year, stated the company.