October 8, 2013 — Biotronik announced it has completed patient enrollment in the iliac arm of its Bioflex-I trial. Under the supervision of Mark Burket, M.D. and chief, Cardiovascular Division at the University of Toledo Medical Center, the trial will evaluate the safety and effectiveness of the Astron and Pulsar-18 stents in the treatment of peripheral vascular disease with a view towards gaining U.S. Food and Drug Administration (FDA) approval.
The Bioflex-I trial is a prospective, non-randomized and multi-center Investigational Device Exemption (IDE) study consisting of two arms: superficial femoral artery (SFA) and iliac. Alongside ongoing enrollment in the SFA arm, the newly completed iliac arm evaluates the use of the Astron stent in the treatment of common or external iliac artery lesions. Astron is CE-marked and commercially available in over 50 countries worldwide. Astron stents were successfully implanted in 160 patients at 34 centers in the United States and Europe, completing enrollment in the iliac arm of the Bioflex-I trial.
For more information: www.clinicaltrials.gov