Interim all-comers results for Biotronik’s Pulsar-18 self-expanding bare-metal stent
Biotronik presented 12-month interim results from the Bioflex Peace trial of its Pulsar-18 self-expanding bare-metal stent for superficial femoral artery disease.
Dr. Jos van den Berg of Switzerland’s University of Bern, presenting for lead investigator Dr. Michael Lichtenberg of Arnsberg, Germany’s Vascular Center, said the Pulsar-18 demonstrated efficacy, with a primary patency rate of 75.0% and freedom from target lesion revascularization of 93.1%. The clinical success rate of 85.0% (defined as improvement in Rutherford class ≥1) was also observed, van den Berg said.
“It is reassuring to see that the clinical outcomes in this real world registry are similar to already published 12-month data,” he said in prepared remarks. “These positive results were obtained with the Pulsar stent, which has a thin-strut design producing a low chronic outward force. As higher COF has been shown to result in higher restenosis rates, Pulsar’s unique design can be combined with minimal oversizing to further reduce COF for better outcomes.”
“Pulsar-18 continues to prove its efficacy and safety in the SFA,” Uhl added. “This interim data is highly encouraging and we look forward to the full data set from BIOFLEX PEACE in 2017, and eventually the 24-month results.”