09
June
2015
|
00:00
Europe/Amsterdam

BIOTRONIK Pulsar-18 Self-Expanding Stent Demonstrates Efficacy in Treating Advanced Superficial Femoral Artery Disease

Investigator-Initiated Registry Reveals 4 French Interventions Are Effective and Safe Even for Long, Occluded Femoropopliteal Lesions

BUELACH, Switzerland, June 9, 2015—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.”

  1. Bosiers M. J Endovasc Ther. 2013, 20 (6).
  2. Lichtenberg M. J Endovasc Ther. 2014, 21 (3).

About BIOTRONIK:

BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.