S.M.A.R.T. Control Vascular Stent System for (SFA) and/or (PPA) Use
Cordis Corporation's S.M.A.R.T. Control Vascular Stent Systems are designed 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 United 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 United States. In the study, freedom from clinically driven target lesion revascularization (TLR) at one year was 87.4 percent. The 12-month primary patency rate for the S.M.A.R.T. Stent was 81.7 percent 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 percent. In addition, all stent fractures were Type I, least severe, and there were no incidents of more severe stent fractures (Type II-V).
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 three of four patients (as measured using Rutherford-Becker classification), and normal Ankle Brachial Index (ABI) in four of five patients at one year.
The system received FDA approval in November 2012
For more information: www.cordis.com