Registry Shows Efficacy of Biotronik's Pulsar-18 Stent in Treating Advanced SFA Disease

June 9, 2015—Biotronik announced that promising clinical results for its Pulsar-18 self-expanding nitinol stent platform were published by Michael Lichtenberg, MD, et al in Clinical Medical Insights: Cardiology. The study confirms the safety and efficacy of the Pulsar-18 device and shows positive patency results for very challenging cases of femoropopliteal disease, stated the company.

In Biotronik’s press release, Dr. Lichtenberg commented, “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. Even [when] confronting these difficult cases, Pulsar-18’s 4-F system yielded strong primary patency.” Dr. Lichtenberg, who served as the lead investigator of the study, is with the Vascular Center Clinic in Arnsberg, Germany.

According to Biotronik, 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, which are indications of a very advanced disease state. Additionally, more than 95% of the lesions were occlusions. All patients underwent a revascularization procedure with implantation of the Pulsar-18 stent. At 12 months after implantation, the overall primary patency rate was 85.4%, and the freedom from target lesion revascularization rate was 87.5%. 

According to the company, Biotronik's highly flexible Pulsar stents are coated with the company’s ProBio, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility. Pulsar-18 is available in diameters of 4 to 7 mm and lengths of 20 to 200 mm, which are all deliverable through a 4-F sheath.

The company also advised that the findings add to the similarly encouraging data in the earlier 4EVER and PEACE trials. In October 2013, the company announced the presentation of these data at CIRSE 2013, the annual congress of the Cardiovascular and Interventional Radiological Society, which was held in Barcelona, Spain. In June 2014, Biotronik announced that the PEACE I all-comers registry was published by Dr. Lichtenberg et al in the Journal of Endovascular Therapy (2014;21:373–380). Also in the Journal of Endovascular Therapy, Marc Bosiers, MD, et al published the 1-year 4EVER data in December 2013 (2013;20;746–756).