Pulsar 18 stent investigator trial results for femoropopliteal disease published in Clinical Medical Insights: Cardiology- Biotronik

Biotronik a leading manufacturer of cardio- and endovascular medical devices, announced the publication of promising clinical results regarding its Pulsar-18 stent platform. Adding to the similarly encouraging data collected in the earlier 4EVER1 and PEACE2trials, the new results published in Clinical Medical Insights: Cardiology further confirm the safety and efficacy of the Pulsar-18 self-expanding nitinol stent, with positive patency results for very challenging cases of femoropopliteal disease.

The investigator-initiated trial was a two center, all-comers, prospective registry that enrolled 36 patients with symptomatic femoropopliteal lesions. The average lesion length was 18.2 cm and all lesions treated were TASC D, both indicative of a very advanced disease state. Additionally, more than 95 percent of the lesions were occlusions. All patients underwent a revascularization procedure with implantation of the Pulsar-18 stent. At 12 months from implantation the overall primary patency rate was 85.4% and the freedom from target lesion revascularization (fTLR) rate was 87.5%.

Comment:The advantage of the Pulsar-18 stent system is that it provides faster recovery time and improved patient comfort following the procedure. The Pulsar-18 nitinol (a mixture of nickel and titanium) stent is coated with a silicon carbide layer that improves its hemocompatibility and biocompatibility . The company also affirms its ease of deliverability using a 4 French sheath.