February 23, 2015
BIOFLEX-I Data Presented for Biotronik's Astron Stent
February 23, 2015—Biotronik announced that data from the iliac arm of the BIOFLEX-I clinical trial were presented by Mark W. Burket, MD, at CRT.15, the Cardiovascular Research Technologies annual scientific meeting, held February 21–24 in Washington, DC. The BIOFLEX-I trial is designed to support US Food and Drug Administration approval of the company’s Astron self-expanding nitinol stent to treat common iliac or external iliac artery disease. The results demonstrated that Astron had successfully met clinical endpoints for safety and efficacy.
According to the company, BIOFLEX-I is a prospective, nonrandomized, multicenter trial. In the iliac arm of the study, 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.
Dr. Burket announced that the 12-month composite endpoint of MAE was 2.1% (P < .001), well below the stent's performance goal, which was based on the trial results of similar self-expanding nitinol iliac stents.
Regarding the trial’s secondary outcomes, Astron's 12-month primary patency rate was 89.8%, and the TLR 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.
Dr. Burket, who is from the University of Toledo Medical Center in Toledo, Ohio, serves as the national principal investigator for the study. In the company’s press release, he commented, “In this trial, Astron handily beat its prespecified performance goal of 15% MAE at 12 months. 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 interventionist's toolkit once approved for use in the United States.”
Designed for iliac arteries, the Astron self-expanding nitinol stent system features a peak-to-valley stent design with S-articulating connecting bars to provide multidirectional flexibility while avoiding fish-scaling in tortuous arteries. Astron stents are coated with ProBio, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue, advised Biotronik.