Johnson & Johnson (NYSE:JNJ) subsidiary Cordis Corp. this week unveiled positive 2-year clinical trial results for its S.M.A.R.T. vascular stent systems in treatment of patients with obstructive superficial femoral artery disease.

Researchers from Cordis’ STROLL trial touted "excellent" clinical results, including freedom from clinically driven target revascularization at 2 years in more than 80% of enrolled patients, nearly half of which were diabetic and nearly a quarter of which entered the trial with total occlusions.

The 2-year patency rate attributed to the devices was just shy of 75% and the primary duplex patency rate was 83.5%, according to a press release.

Cordis reported no major adverse events at 30 days following the initial index procedure and no or minimal signs of peripheral artery disease reported in 80% of patients at 2 years. Researchers further noted a low 2% stent fracture rate, with all incidents classified as Type I, the least severe type of fracture.

The STROLL trial is a multi-center, non-randomized, single-arm prospective trial comparing the S.M.A.R.T. vascular stent systems against a published performance goal. Researchers plan to follow patients out to 3 years. The results were released during late-breaking clinical trial sessions at this year’s International Symposium on Endovascular Therapy in Miami Beach, Fla.

Late last year U.S. regulators approved the S.M.A.R.T. systems for use in the superficial femoral artery and/or the proximal popliteal artery, making the stent systems the only ones with FDA labeling for both indications, according to a press release. The approval was granted in part on data obtained in the S.M.A.R.T. investigational device exemption trial.

The devices have been on the international market since 1999.