Biotronik’s Dynetic-35 Iliac Stent to Be Evaluated in BIONETIC-I Study

September 27, 2021—Biotronik announced the beginning of enrollment in the BIONETIC-I study of the safety and efficacy of the company’s Dynetic-35 cobalt-chromium, balloon-expandable stent system for the treatment of atherosclerotic peripheral artery disease lesions in the iliac arteries. The study will also evaluate the use of the stent system in association with Biotronik’s Passeo-35 Xeo peripheral dilatation catheter.

The next-generation Dynetic-35 iliac stent system is 6-F compatible across the entire size matrix and is indicated for the treatment of de novo or restenotic lesions in the iliac arteries. In July 2020, the company announced the launch of the Dynetic-35 in the European Union and other countries that recognize CE Mark approval.

According to Biotronik, the prospective, international, multicenter, single-arm, observational study will evaluate treatment of iliac lesions in approximately 159 patients with up to 60-month follow-up. The primary endpoint is major adverse events (MAEs) at 12 months. MAEs include device- or procedure-related death within 30 days post-index procedure, clinically driven target lesion revascularization, and major index limb amputation up to 12 months post-index procedure.

The study’s principal investigator is Professor Marianne Brodmann, MD, Head of the Clinical Division of Angiology, Department of Internal Medicine at Medical University Graz in Graz, Austria.

“I am enthusiastic to collect new clinical data to add to the body of literature regarding iliac artery bare-metal stenting, as we have not had new data in this field for some time,” stated Prof. Brodmann in the company’s press release.

Koen Keirse, MD, vascular surgeon at the Tienen Medical Center in Tienen, Belgium, enrolled the first patient in the study.

“I was impressed by the performance of the latest balloon-expandable iliac stent on the market,” commented Dr. Keirse in the company’s press release. “The cobalt-chromium structure is, to me, very important. I am sure that the Dynetic-35 stent’s unique characteristics and fantastic size range—including stents up to 78 mm—will be of added value in many cath labs.”