Biotronik Showcases Positive Results for Pulsar-18 Stent in the Superficial Femoral Artery

December 13, 2016 — Biotronik announced the presentation of data confirming the efficacy of the Pulsar-18 bare metal self-expanding stent (BMS SE) at VEITHsymposium 2016, Nov. 15-19 in New York. Jos C. van den Berg, University of Bern, 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, 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 percent and freedom from target lesion revascularization (TLR) of 93.1 percent confirm the results of previous Pulsar studies.^1,2 Clinical success of 85 percent (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 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 stents are manufactured with Biotronik’s proBIO coating, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue. Pulsar-18 is available in diameters of 4 to 7 mm, all deliverable through a 4 F sheath.

The Pulsar-18 stent is an investigational device limited by United States law to investigational use.

For more information: www.biotronik.com

References:

1. Bosiers M et al. J Endovasc Ther. 2013, 20(6).

2. Lichtenberg M et al. J Endovasc Ther. 2014, 21(3).

3. Zhao H et al. Cardiovasc Intervent Radiol. 2009, 32(4).