On 5 February 2013, IDEV Technologies announced the publication of positive clinical outcomes for the Supera peripheral stent system in the Journal of American College of Cardiology (JACC) Cardiovascular Interventions. The publication, “Treatment of Complex Atherosclerotic Popliteal Artery Disease with a New Self-Expanding Interwoven Nitinol Stent: 12-Month Results of the Leipzig Supera Popliteal Registry,” was authored by Dierk Scheinert and colleagues from Park Krankenhaus Hospital in Leipzig, Germany.
In the Leipzig experience, 101 consecutive patients were implanted with 125 Supera stents and studied. 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 84.3mm with a range of 40mm to 240mm. The primary patency rate at 12 months was 87.7%. Zero stent fractures were reported.
“To achieve superficial femoral artery-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,” noted Scheinert. “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.”
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 pre-specified inclusion and exclusion criteria. As a result, the patient cohort represents a real-world population recognisable by physicians.
IDEV president and chief executive officer, Chris Owens, commented, “We are excited to see such encouraging results from this targeted popliteal application of the Supera stent. Physicians continue to report consistently strong results in using Supera to treat femoropoliteal disease.”
IDEV is currently working with the FDA on a randomized IDE trial for the study of popliteal stenting in the United States.
The Supera stent is engineered with proprietary interwoven wire technology that mimics vascular anatomy. The Supera stent is currently cleared in the USA 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 following failed percutaneous transluminal angioplasty.