Biotronik Completes Iliac-Arm Enrollment in BIOFLEX-I Study

October 8, 2013—Biotronik, Inc. (Lake Oswego, OR) announced that it has completed patient enrollment in the iliac arm of its BIOFLEX-I trial evaluating the safety and effectiveness of the company's Astron and Pulsar-18 stents in the treatment of peripheral vascular disease. Data from the trial, which is being conducted under an investigational device exemption (IDE), will be used to support US Food and Drug Administration approval of the devices. The trial is being led by national primary investigator Mark W. Burket, MD, who is Chief of the Cardiovascular Division at the University of Toledo Medical Center in Toledo, Ohio.

According to the company, the BIOFLEX-I trial is a prospective, nonrandomized, multicenter IDE study consisting of two arms: superficial femoral artery (SFA) and iliac. The newly completed iliac arm evaluates the use of the Astron stent in the treatment of common or external iliac artery lesions. Astron stents were successfully implanted in 160 patients at 34 centers in the United States and Europe, to complete enrollment in the iliac arm of the BIOFLEX-I trial. Enrollment in the SFA arm is ongoing. The Astron device has received European CE Mark approval and is commercially available in more than 50 countries worldwide, advised Biotronik.

In the company's press release, Dr. Burket commented, “When treating disease in the iliac arteries, it's important to have a variety of tools at your disposal. The Astron stent is an excellent option in the self-expanding category. Its flexibility, ease of deployment, and passive ProBio coating make it a suitable choice for many patients.”