Biotronik has announced the publication of promising clinical results regarding its Pulsar-18 stent platform. Adding to the data collected in the earlier 4EVER1 and PEACE2 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, Vascular Centre 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-centre, all-comers, prospective registry that enrolled 36 patients with symptomatic femoropopliteal lesions. The average lesion length was 18.2cm and all lesions treated were TASC D, both indicative of a very advanced disease state. Additionally, more than 95% of the lesions were occlusions. All patients underwent a revascularisation 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 revascularisation (TLR) rate was 87.5%.
“The advantage of the Pulsar-18 stent system is that it offers a complete 4 French revascularisation solution, which means faster recovery time and improved patient comfort following the procedure. While several studies have already proven Pulsar-18 in everyday use, these results further support Pulsar-18’s efficacy even in longer lesions,” stated Alexander Uhl, vice president marketing, Biotronik Vascular Intervention. “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. Pulsar-18’s high flexibility and low chronic outward force appear to minimise the mechanical inflammatory response that otherwise contributes to restenosis.”