BIOTRONIK Vascular Enters U.S. with First Peripheral Stent Implant in BIOFLEX-I IDE Clinical Trial

BIOTRONIK announced today that the first endovascular procedure was completed in the BIOFLEX-I clinical trial—a trial set to evaluate the safety and performance of the Astron and Astron Pulsar self-expanding peripheral stents. Dr. Vipin Khetarpal, a Co-Investigator with Dr. Safwan Kassas at Michigan Cardiovascular Institute, performed the procedure in the United States at Covenant Medical Center in Saginaw, Michigan.

The BIOFLEX-I trial is a prospective, nonrandomized, multicenter, investigational device exemption (IDE) study that will utilize BIOTRONIK’s Astron and Astron Pulsar stents for the treatment of peripheral arterial disease . The study uniquely targets two peripheral indications: The Astron stent is designed and indicated for use in treatment of common or external iliac lesions, while the Astron Pulsar stent will be used for the treatment of femoropopliteal lesions. More than 350 patients will be enrolled in the study, which is registered on www.clinicaltrials.gov.

Dr. Mark Burket from the University of Toledo is national principal investigator of the BIOFLEX-I study. He commented, “BIOFLEX-I will provide additional insight and experience in the clinical application of the Astron and Astron Pulsar stents. The Astron features a 5.2F proximal shaft that allows contrast injection while positioning the device, enhancing accurate stent deployment. Precise stent placement is essential for good clinical outcomes. The Astron Pulsar's unique low profile allows femoral interventions to be performed entirely with a 4F sheath—a remarkable step forward. Miniaturization of the vascular sheath provides the potential for early postprocedure ambulation, fewer entry-site complications and improved distal flow during the procedure. These features are especially important in patients with diffuse vascular disease.”

The Astron Pulsar stent has a dedicated, novel design for treating disease of the femoropopliteal segment. Its multi-element construction allows each individual segment to work independently, providing enhanced flexibility in three dimensions. The Astron Pulsar stent also offers the industry’s lowest crossing profile to facilitate a complete, 4F compatible delivery system across all stent sizes.

The Astron stent is designed to provide superb vessel scaffolding and support while allowing optimal stent flexibility with its unique peak-to-valley architecture. The Astron stent delivery system is compatible with a 6F introducer sheath and a 0.035" guidewire.

Both the Astron and Astron Pulsar stents utilize BIOTRONIK’s proprietary PROBIO passive coating, employed to enhance stent biocompatibility and to improve long-term outcomes through quick and complete endothelialization within the vessel wall.

Commenting on the first Astron implant of BIOFLEX-I, Alain Aimonetti, BIOTRONIK Vascular Intervention Vice President of Sales & Marketing, said, “Enrolling the first patient in the BIOFLEX-I study was an important milestone for BIOTRONIK’s expanding presence in the United States. We are very excited at the prospect of offering these unique products to U.S. patients. The Astron and Astron Pulsar stent technologies have proven to be highly reliable in more than 66,000 peripheral vascular implantations worldwide.”

BIOTRONIK understands the dynamic and evolving discipline of peripheral vascular intervention. Increasingly complex diseases observed in today’s patients are driving the emergence of endovascular therapy—and the techniques physicians are using to treat these prevalent conditions. Peripheral intervention technology continues to advance, further expanding the minimally invasive options available via dedicated, innovative devices. BIOTRONIK remains at the forefront, delivering these state-of-the-art products to improve patient care.

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

More information: www.biotronik.com

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Contact:

BIOTRONIK SE & Co. KG
Sandy Hathaway
Senior Director, Global Communications
Tel. +49 (0) 30 68905 1602
Email: sandy.hathaway@biotronik.com