Investigator-Initiated Registry Reveals 4 French Interventions Are Effective and Safe Even for Long, Occluded Femoropopliteal Lesions / Vascular Intervention
(PresseBox) (Buelach, Switzerland, )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 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 Dr. Michael Lichtenberg, 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% and the freedom from target lesion revascularization (fTLR) rate was 87.5%.
"The advantage of the Pulsar-18 stent system is that it offers a complete 4 French revascularization 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 Dr. 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."
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.
References: 1 Bosiers M. J Endovasc Ther. 2013, 20 (6). 2 Lichtenberg M. J Endovasc Ther. 2014, 21 (3).