The US Food and Drug Administration (FDA) has approved Cordis’ S.M.A.R.T. vascular stent systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery.
The S.M.A.R.T. CONTROL stents are the first devices now available in the US for use in both Iliac and SFA indications, according to the company.
The approval was based on the positive outcome data from a 250-patient investigational device exemption (IDE) trial, designed to demonstrate the safety and efficacy of the vascular stents.
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.
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."
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.