February 23, 2015 – Biotronik announced the presentation of data from the iliac arm of the BIOFLEX-I clinical trial at the Cardiovascular Research Technologies (CRT) conference in Washington, D.C. The BIOFLEX-I trial is designed to support U.S. Food and Drug Administration (FDA) approval of the Astron self-expanding nitinol stent to treat patients suffering from common iliac or external iliac artery disease. National principal investigator for the study, Mark W. Burket, M.D., University of Toledo Medical Center, Ohio, presented results demonstrating that Astron had successfully met clinical endpoints for safety and efficacy.
For the iliac arm of the prospective, non-randomized, multi-center trial, Astron stents were implanted in 161 patients at 34 centers in the United States, Canada and Europe. The trial’s primary endpoint was the composite rate of procedure or stent-related major adverse events (MAEs) at 12 months after implantation. MAEs were defined as 30-day mortality, clinically-driven target lesion revascularization (TLR) and limb amputation at 12 months. During the “Breakfast Symposium: Best Abstracts” at CRT, Burket announced that the 12-month composite endpoint of MAE was only 2.1 percent (p<0.001), well below the stent’s performance goal of 15 percent, which was based on the trial results of similar self-expanding nitinol iliac stents.
Burket reported that secondary outcomes were also positive. In the trial, Astron’s 12-month primary patency rate was 89.8 percent, and the TLR rate was 1.4 percent. Additionally, patients demonstrated improvement in their ambulatory function and quality of life at 12 months compared to baseline as evaluated by the walking impairment questionnaire score, a common screening tool for peripheral arterial disease.
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