BIONETIC-I Begins Enrollment for Study of Iliac Artery Treatment With BIOTRONIK’s Dynetic-35 Cobalt Chromium Balloon-Expandable Stent System

Study Will Also Evaluate Safety and Efficacy of the Stent System in Association With Use of the Passeo-35 Xeo Peripheral Dilatation Catheter

September 29, 2021 — BIOTRONIK is proud to announce the enrollment of the first patient in the BIONETIC-I study of the safety and efficacy of the 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 first patient was enrolled by investigator Dr. Koen Keirse, Vascular Surgeon at the Tienen Medical Center in Tienen, Belgium.

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.

"I was impressed by the performance of the latest balloon-expandable iliac stent on the market. The cobalt chromium structure is, to me, very important," said Dr. Keirse. "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."

 "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," added Principal Investigator Prof. Marianne Brodmann, Head of the Clinical Division of Angiology, Department of Internal Medicine at Medical University Graz in Graz, Austria.

The next-generation Dynetic-35 iliac stent system, which was launched in the European Union and other CE mark-accepting countries last year, 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.

"These products provide new treatment options, including the opportunity to perform iliac interventions using radial access, thanks to their low-profile and with Dynetic-35, our commitment to thin-strut stent design" said Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. "We look forward to the results of the BIONETIC study which will demonstrate these benefits in a multi-center, international clinical setting".

*Note for Australia: Passeo-35 Xeo not approved by Therapeutic Goods Administration for use in the common iliac arteries.

Dynetic, Passeo and Xeo are trademarks or registered trademarks of the BIOTRONIK Group of Companies.