Interim BIOFLEX PEACE Data Presented for Biotronik’s Pulsar-18 Stent in SFA Treatment
November 23, 2016—Biotronik announced that interim data from the BIOFLEX PEACE all-comers trial, which confirm the efficacy of the company’s Pulsar-18 bare-metal, self-expanding stent (BMS SE) in the treatment of superficial femoral artery (SFA) disease, were presented at the 43rd annual VEITHsymposium, which was held November 15–19, 2016, in New York, New York.
Jos C. van den Berg, MD, from Ospedale Regionale di Lugano, Switzerland, presented the results for Pulsar-18 during the symposium’s main program on behalf of the trial’s lead investigator, Michael Lichtenberg, MD, of the Vascular Center, Arnsberg, Germany.
BIOFLEX PEACE is a prospective, multicenter registry examining 151 patients in an all-comers enrollment. The study’s primary endpoint is primary patency at 12 months.
According to the company, the available 12-month interim results demonstrate that the Pulsar-18 BMS SE is an effective treatment option in the SFA. The primary patency rate of 75% and freedom from target lesion revascularization of 93.1% confirm the results of previous Pulsar studies. Investigators observed a clinical success of 85% (defined as improvement in Rutherford class ≥ 1).
In Biotronik’s announcement, Dr. van den Berg commented, “It is reassuring to see that the clinical outcomes in this real-world registry are similar to already published 12-month data. These positive results were obtained with the Pulsar stent, which has a thin strut design producing a low chronic outward force (COF).” Dr. van den Berg explained, “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.”
The company advised that it will have a full data set from BIOFLEX PEACE in 2017, and eventually the registry’s 24-month results.
In the United States the Pulsar-18 BMS SE is an investigational device and is not commercially available. It is limited by federal law to investigational use only.