Cardio device maker Biotronik is seeing some positive data presented at this week’s Cardiovascular Research Technologies (CRT) conference in Washington, DC. The data results from the iliac arm of the BIOFLEX-I clinical trial, which is designed to support U.S. FDA approval of the Astron self-expanding nitinol stent to treat patients suffering from common iliac or external iliac artery disease.
For the iliac arm of the prospective, non-randomized, multi-center BIOFLEX-I trial, Astron stents were implanted in 161 patients at 34 centers in the US, 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.
National principal investigator for the study, Dr. Mark W. Burket, University of Toledo Medical Center, Ohio, presented results demonstrating that Astron had successfully met clinical endpoints for safety and efficacy.
During the “Breakfast Symposium: Best Abstracts” at CRT, Dr. Burket announced that the 12-month composite endpoint of MAE was only 2.1% (p<0.001), well below the stent’s performance goal, which was based on the trial results of similar self-expanding nitinol iliac stents.
Secondary outcomes were also reportedly positive with a 12-month primary patency rate of 89.8%, and a TLR rate of 1.4%.
“In this trial, Astron handily beat its pre-specified performance goal of 15% MAE at 12 months,” stated Dr. Burket.
“Astron has already proven itself as an excellent treatment option abroad in routine clinical practice for patients suffering from iliac artery disease. As the results of BIOFLEX-I show, Astron will be a helpful addition to the interventionalist’s toolkit once approved for use in the US.”
Source: Biotronik AG