Long-Lesion Study Supports IDev's Supera Stent to Treat SFA and Popliteal Disease

May 17, 2011—IDev Technologies, Inc. (Webster, TX) announced that data from a long-lesion study of 182 patients with significantly diseased superficial femoral arteries (SFAs) and popliteal arteries showed high patency rates and no stent fractures after treatment with the company's Supera Veritas peripheral vascular stent system. The data were based on an analysis by Andre Molenaar, MD, and Peter Haarbrink, MD, and presented at the Vaatdagen (Vascular Days) 2011 conference in Noordwijkerhout, The Netherlands.

According to the company, patients were treated and followed during a 2-year period. They represented an extremely challenging cohort with highly calcified and long lesions in the SFA that at times encompassed the proximal popliteal artery and/or popliteal artery alone. IDev noted that these results were achieved in vessels with significant disease, atypical extremely long lesions, and without the use of clopidogrel.

The SFA plus proximal popliteal treated artery cohort consisted of 159 patients with an average lesion length of 240 mm, 40% TASC D classification, and 57% total occlusions, with an average of approximately two stents per patient. A patency rate of 74% was achieved at 12 months as measured by duplex ultrasound. Twenty-three patients were treated with a Supera stent in the popliteal artery, with an average stent length of 142 mm and a patency rate of 83% at 12 months as measured by duplex ultrasound. A subgroup analysis by x-ray at 24 months showed no stent fractures.

“These are outstanding and noteworthy results which demonstrate that Supera is a market-changing technology when used appropriately,” commented Dr. Molenaar. Dr. Haarbrink added, “The average stent length deployed was 240 mm, ranging from 40 to 550 mm. Compared with other stent trials, and even the Leipzig SUPERA registry, these are much longer lesions with significant disease.”

Dr. Molenaar remarked that no concomitant treatment occurred with antiplatelet medication. “Patients received aspirin postprocedure, but none of these patients received [clopidogrel] following their stent procedures. We can assume the results would have had an even more dramatic improvement from baseline had we supplemented our procedure with this treatment. It is also clear to us that we utilize Supera for the most challenging cases, constantly testing the device, and still receive exceptional results. We look forward to continuing our analysis of Supera.”