Biotronik enters USA with first peripheral stent implant in BIOFLEX-I IDE trial


Biotronik announced finalisation of the first endovascular procedure in the BIOFLEX-I clinical trial, which evaluates the safety and performance of the company’s Astron and Astron Pulsar self-expanding peripheral stents. 

Vipin Khetarpal, co-investigator with Safwan Kassas at Michigan Cardiovascular Institute, performed the procedure at Covenant Medical Center in Saginaw, Michigan, USA.

The BIOFLEX-I trial is a prospective, non-randomised, multicentre, investigational device exemption (IDE) study that will enrol more than 350 patients. The trial is set to evaluate the performance of the Astron stent in treatment of common or external iliac lesions, and the Astron Pulsar’s performance in femoropopliteal lesions treatment.

Mark Burket, University of Toledo and national principal investigator of the study, 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. Miniaturisation 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.