Twelve-Month Outcomes Published for Idev's Supera Stent System in Treating Popliteal Artery Disease

February 5, 2013—Idev Technologies, Inc. (Webster, TX) announced the publication of positive clinical outcomes for the Supera peripheral stent system. The findings were published by Dierk Scheinert, MD, et al from Park Krankenhaus Hospital in Leipzig, Germany, in the Journal of the American College of Cardiology: Cardiovascular Interventions (2013;6:65–71).

As summarized in the company's press release, the Leipzig study was composed of 101 consecutive patients who were implanted with 125 Supera stents. Total occlusions were present in 47.5% of the patients, and 49.5% of the patients were diabetic. The mean length of implanted stents was 84.3 mm, with a range of 40 to 240 mm. The primary patency rate at 12 months was 87.7%. There were no reported stent fractures.

“To achieve SFA-like patency results at 12 months in stenting of these significantly diseased popliteal arteries validates Supera as a treatment option for patients that would not have been offered a standard nitinol stent for their disease," Prof. Scheinert commented in the company's press release. "The finding of zero stent fractures in the popliteal artery, a vessel subject to high forces of compression, torque, rotation, and flexion, validates the unique Supera design and the associated benefits of this vascular mimetic stent.”

Idev advised that to derive information that was both scientifically and clinically meaningful, the registry intentionally allowed enrollment of patients with a wide range of obstructions, including long lesions, total occlusions, and calcified vessels, without prespecified inclusion and exclusion criteria. As a result, the patient cohort represents a real-world population recognizable by physicians.

Additionally, Idev is currently working with the US Food and Drug Administration on a randomized investigational device exemption trial for the study of popliteal stenting in the United States. The Supera stent is currently cleared in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms. In multiple other countries, the Supera stent is indicated for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use after failed percutaneous transluminal angioplasty.