Cordis has obtained regulatory approval from the US Food and Drug Administration (FDA) to use its S.M.A.R.T. CONTROL Vascular Stent systems in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA).
The Stent systems, which are used in both Iliac and SFA indications, are the first devices now available in the US, claims the company.
The FDA approval was based on the positive outcome data from 250-patient based investigational device exemption (IDE) STROLL trial
The results demonstrated 12-month primary patency rate of 81.7%, as demonstrated with Kaplan Meier analysis, and freedom from clinically driven target lesion revascularisation of 87.4 at one year.
The results also showed no major adverse events at 30 days and a low one-year stent fracture rate of 2.0%, with only the least severe Type I fractures.
In addition to the study outcomes, Health Related Quality of Life surveys showed minimal or no signs of PAD in 3 of 4 patients (as measured using the Rutherford-Becker classification), and normal Ankle Brachial Index (ABI) in 4 of 5 patients at one year.
Cardiovascular Research Foundation endovascular services director and study co-national principal investigator Dr William Gray said, "These outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery."