June 10, 2015 - Biotronik announced the publication of promising clinical results regarding its Pulsar-18 peripheral stent platform. Adding to the similarly encouraging data collected in the earlier 4EVER and PEACE trials, 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 aim of the study was to verify patency results for the Pulsar-18 stent system in routine clinical treatment of long, occlusive femoropopliteal lesions," commented lead investigator Michael Lichtenberg, M.D., Vascular Center Clinic, Arnsberg, Germany. "Even confronting these difficult cases, Pulsar-18's 4 French system yielded strong primary patency."
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 percent and the freedom from target lesion revascularization (fTLR) rate was 87.5 percent.
Pulsar stents feature an innovative, highly flexible design coated with proBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility, which is believed to contribute to its excellent clinical results. Pulsar-18 is available in diameters of 4 to 7 mm and lengths of 20 to 200 mm, all deliverable through a 4 French sheath.
For more information: www.biotronik.com