Biotronik reports positive data from Pulsar-18 stent trial

Biotronik has published new clinical trial data from a new study of its Pulsar-18 self-expanding stent, showing its effectiveness in the treatment of advanced superficial femoral artery disease.

The investigator-initiated trial was a two-centre, all-comers, prospective registry that enrolled 36 patients with symptomatic femoropopliteal lesions, with all patients undergoing a revascularisation procedure with implantation of the Pulsar-18 stent.

At 12 months from implantation, the overall primary patency rate was 85.4 percent, while the freedom from target lesion revascularisation rate was 87.5 percent. Positive patency results were achieved even in very challenging cases of femoropopliteal disease.

When added to the similarly encouraging data collected in the earlier 4EVER and PEACE trials, these results – published in Clinical Medical Insights: Cardiology – further confirm the safety and efficacy of the self-expanding nitinol stent.

Dr Alexander Uhl, vice-president for marketing at Biotronik's vascular intervention business, said: "We believe that the high patency and low TLR rates, evident in all Pulsar-18 studies published so far, are the result of the stent's unique design."

This comes after the firm reported positive trial data for its Orsiro hybrid drug-eluting stent last month.