Noticias

Noticias

  • Título: BIOTRONIK Pulsar-18 Self-Expanding Stent Demonstrates Efficacy in Treating Advanced Superficial Femoral Artery Disease
  • Fecha: 09-06-2015

  • 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 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin, Germany Tel +49 (0) 30 68905-1414 Fax +49 (0) 30 68905-961414 www.biotronik.com Date: Page: Page: 2/2 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.”

    About Pulsar-18

    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.

    About BIOTRONIK One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world’s first 4 Frenchcompatible 200mm peripheral stent; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology.

    For more information, visit: www.biotronik.com References: 1 Bosiers M. J Endovasc Ther. 2013, 20 (6). 2 Lichtenberg M. J Endovasc Ther. 2014, 21 (3). Contact: Manuela Schildwächter Senior Manager PR & Communications BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin, Germany Tel. +49 (0) 30 68905 1414 Email: press@biotronik.com



  • Fuente: endovascular.es