BIOTRONIK has completed the BIOFLEX-I clinical trial of its peripheral stents - Astron and Astron Pulsar.
The trial was conducted at Michigan Cardiovascular Institute at Covenant Medical Center by Vipin Khetarpal, a co-investigator with Safwan Kassas.
The study is a investigational device exemption (IDE), multicenter, nonrandomized trial to assess safety and performance of peripheral stents.
The Astron stent is designed and indicated to treat common or external iliac lesions, and the Astron Pulsar stent is designed to treat femoropopliteal lesions.
National principal investigator of the BIOFLEX-I study Mark Burket of University of Toledo said the Astron features a 5.2F proximal shaft that allows contrast injection while positioning the device, enhancing accurate stent deployment.
"The Astron Pulsar’s low profile allows femoral interventions to be performed entirely with a 4F sheath — a remarkable step forward," Burket said.
"Miniaturization of the vascular sheath provides the potential for early postprocedure ambulation, fewer entry-site complications and improved distal flow during the procedure,".