FLAGSTAFF, Ariz.--(BUSINESS WIRE)-- W. L. Gore & Associates (Gore) shares data from the Scandinavian study designed to compare one year patency rates of the GORE® PROPATEN® Vascular Graft with standard ePTFE grafts (GORE-TEX® Stretch Vascular Graft). Investigators presented their findings at the European Society for Vascular Surgery (ESVS) Annual Meeting, where they reported statistically significant advantages in primary and secondary one year patencies in GORE PROPATEN Vascular Graft (image) patients.
The independent study randomized 569 patients with chronic lower limb ischemia having a planned femoral-femoral bypass or femoropopliteal bypass across 11 centers in Denmark, Norway, and Sweden between April 2006 and February 2009. Patency was assessed by duplex ultrasound scanning, and 546 patients (96 percent) had adequate follow-up at one year. At one year, overall primary and secondary patency rates for the GORE PROPATEN Vascular Graft showed statistically significant improvement over standard ePTFE grafts. One year primary patency was 86.4 percent in GORE PROPATEN Vascular Graft patients compared with 79.9 percent in patients with standard ePTFE grafts. One year secondary patency was 88 percent in patients with GORE PROPATEN Vascular Grafts compared with 81 percent in ePTFE graft patients. Furthermore, as the severity of disease increased (critical limb ischemia), the benefit of the heparin bonding increased. GORE PROPATEN Vascular Grafts showed a significant improvement in primary patency over ePTFE for patients with critical limb ischemia (80 percent vs. 70 percent). The study excluded acute ischemic patients, patients with expected poor surveillance and/or allergy to heparin.
“Even though modern bypass surgery has improved clinical outcomes in general, the GORE PROPATEN Vascular Graft shows a statistically significant improvement in primary and secondary patency rates,” said the principal investigator, Dr. Jes Lindholt, associate professor, PhD, for the Vascular Research Unit at Viborg Hospital in Denmark. “Another interesting aspect is that as the patients’ initial disease worsens, the more efficient the GORE PROPATEN Vascular Graft becomes by reducing the risk of occlusion by 50 percent for patients with critical limb ischemia. We have seen that GORE PROPATEN Vascular Graft keeps its promise as shown in the previously conducted prospective and retrospective studies.”
The GORE PROPATEN Vascular Graft is specifically designed for those vascular procedures in which the risk of acute graft thrombotic failure is of clinical concern. The GORE PROPATEN Vascular Graft harnesses the anticoagulant properties of heparin directly at the luminal surface of the graft. The proprietary end-point attachment mechanism serves to anchor heparin molecules to the luminal surface while still maintaining heparin’s intrinsic bioactive properties. The result is a thromboresistant graft surface that retains its bioactive properties over time.
The GORE PROPATEN Vascular Graft has previously demonstrated improved thromboresistance and patency compared to standard ePTFE grafts in pre-clinical in vivo tests. The thromboresistant surface technology employed on the GORE PROPATEN Vascular Graft is designed to maintain sustained bioactivity, thus increasing the potential for performance improvement and increased patency.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 13th consecutive year. For more information, visit www.goremedical.com.
Products listed may not be available in all markets. GORE®, GORE-TEX®, PROPATEN®, and designs are trademarks of W.L. Gore & Associates. AP4511-EN1 OCTOBER 2010
