NEW YORK, US and BUELACH, Switzerland, November 21, 2016– BIOTRONIK announced the presentation of data confirming the efficacy of the Pulsar-181
bare metal self-expanding stent (BMS SE) at VEITHsymposium 2016. Dr. Jos C. van den Berg, Ospedale Regionale di Lugano, Switzerland, presented the encouraging interim results for Pulsar-18 in treatment of superficial femoral artery (SFA) disease during the symposium’s main program on behalf of lead investigator for the BIOFLEX PEACE all-comers trial, Dr. Michael Lichtenberg, Vascular Center, Arnsberg, Germany.BIOFLEX PEACE is a prospective, multi-center registry examining 151 all-comers; the primary endpoint is primary patency at 12 months. The available 12-month interim results demonstrate that Pulsar-18 is an effective treatment option in the SFA. The primary patency rate of 75.0% and freedom from target lesion revascularization (TLR) of 93.1% confirm the results of previous Pulsar studies.1, 2
Clinical success of 85.0% (defined as improvement in Rutherford class ≥1) has also been observed.“It is reassuring to see that the clinical outcomes in this real world registry are similar to already published 12-month data,” stated Dr. van den Berg. “These positive results were obtained with the Pulsar stent, which has a thin strut design producing a low chronic outward force (COF). As higher COF has been shown to result in higher restenosis rates3
, 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,” commented Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “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.”
- CAUTION – Investigational device. Limited by United States law to investigational use.
- Bosiers M et al. J Endovasc Ther. 2013, 20(6).
- Lichtenberg M et al. J Endovasc Ther. 2014, 21(3).
- Zhao H et al. Cardiovasc Intervent Radiol. 2009, 32(4).
- Not currently available in the United States.