Biotronik announces results of BIOFLEX-I trial


Biotronik has announced the presentation of promising data from the iliac arm of the BIOFLEX-I clinical trial at the Cardiovascular Research Technologies conference (21–24 February, Washington, DC, USA).

The BIOFLEX-I trial is designed to support 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, University of Toledo Medical Center, USA, presented results demonstrating that Astron had successfully met clinical endpoints for safety and efficacy.

For the iliac arm of the prospective, non-randomised, multicentre BIOFLEX-I trial, Astron stents were implanted in 161 patients at 34 centres in the USA, Canada and Europe. The trial’s primary endpoint was the composite rate of procedure or stent-related major adverse events at 12 months after implantation. Major adverse events were defined as 30-day mortality, clinically-driven target lesion revascularisation and limb amputation at 12 months. During the “Breakfast Symposium: Best Abstracts” at the conference, Burket announced that the 12-month composite endpoint of major adverse event was 2.1% (p<0.001), which was below the stent’s performance goal 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%, and the target lesion revascularisation rate was 1.4%. 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.

Astron has had CE mark since 2003 and is currently available in 45 countries, where they have been used in over 55,000 patients worldwide.