Healthcare Industry News: dialysis access
News Release - December 11, 2007
W. L. GORE & ASSOCIATES ANNOUNCES SUMMARY OF GORE PROPATEN VASCULAR GRAFT STUDY DATA PRESENTED AT 34TH ANNUAL VEITHSYMPOSIUM™
Multi-year, multi-site data adds to the growing body of evidence for the GORE PROPATEN Vascular GraftFLAGSTAFF, Ariz.--(HSMN NewsFeed)-- W. L. Gore & Associates (Gore) announced that interim results from multi-year, multi-center studies using the GORE PROPATEN Vascular Graft were presented recently at the 34th Annual VEITHsymposium™ in New York. The GORE PROPATEN Device is the first device with an ePTFE-heparin combination that is designed to reduce thrombosis (clotting), a common cause of graft failure. The average one-year primary patency from all the reported literature on the GORE PROPATEN Vascular Graft in below-knee bypasses has been reported to be 80 percent.
On the one-year anniversary of the commercial launch of the GORE PROPATEN Vascular Graft in the United States, several presentations at this year’s VEITHsymposium add to the growing body of evidence for the use of this graft in lower-limb and dialysis access applications.
Prof. Dr. André Nevelsteen, MD, PhD, FRCS, University Hospital Gasthuisberg, Belgium, reported data from two studies. The GORE PROPATEN (Vascular Graft) European Product Evaluation Study (PEPE) is a non-randomized, multi-center study evaluating the use of GORE PROPATEN Vascular Graft in lower limb applications. The one-year primary patency for 87 implants at the above-knee femoropopliteal position, 37 implants at the below-knee femoropopliteal position and 15 implants at the below-knee infrapopliteal position were reported to be 83 percent, 74 percent and 79 percent, respectively.
Another retrospective, single-center, non-randomized study compared the GORE PROPATEN Vascular Graft to autologous saphenous vein (ASV) bypasses implanted during the same time period. This study showed no significant difference between the two groups for primary patencies at two years. The two-year primary patency for 86 GORE PROPATEN Vascular Graft implants and 12 ASV implants in the above-knee femoropopliteal position was 83 percent and 80 percent, respectively. The two-year primary patency for 57 GORE PROPATEN Vascular Graft implants and 48 ASV bypasses in the below-knee femoropopliteal position was 83 percent and 72 percent, respectively. The two-year primary patency for 97 GORE PROPATEN Vascular Graft implants and 50 ASV bypasses in the below-knee infrapopliteal position was 69 percent and 64 percent, respectively.
Patrick Peeters, MD, at Imelda Hospital in Belgium, also reported on the three-year follow-up of a prospective, non-randomized, multi-center study of GORE PROPATEN Vascular Graft in lower limb bypass. One hundred and fifty-three GORE PROPATEN Vascular Graft patients were included in the study. After one year, 101 patients were seen for control, with an average primary patency rate of 80.8 percent. One-year follow-up data was available for 53 implants at above-knee femoropopliteal position, 29 implants at below-knee femoropopliteal position and 19 implants at the below-knee infrapopliteal, and reported primary patency rates to be 82.4 percent, 80.8 percent and 77.2 percent, respectively. After three years, 45 patients were seen for control and an average primary patency of 74.3 percent was obtained. Primary patency rates were based on 21 above-knee femoropopliteal implants, 15 below-knee femoropopliteal implants and nine implants in below-knee infrapopliteal position, and were reported to be 75.1 percent, 74.5 percent and 72.6 percent, respectively. Peeters concluded that these initial results look very promising, but that caution is advised due to the limited number of patients they are based on.
Ingemar Davidson, MD, PhD, FACS, at University of Texas, Southwestern Medical Center in Dallas, Texas, presented interim results of a prospective, non-randomized, single-center study comparing GORE PROPATEN Vascular Graft to a non heparin-bonded graft in difficult patients for hemodialysis access application. Preliminary results suggest fewer number of thrombotic events in the GORE PROPATEN Device group as compared to the non heparin-bonded graft group.
John Ross, MD, at Bamberg County Memorial Hospital in South Carolina, reported on a prospective, non-randomized, single-center study evaluating the use of the GORE PROPATEN Vascular Graft for hemodialysis access creation. Consecutive implants in patients with compromised veins or those that have low flow were enrolled in this evaluation. Ninety-five patients are enrolled in the study, with 49 patients having had six-month follow-up. Preliminary results indicate positive results of the GORE PROPATEN Vascular Graft in this patient population.
“We are pleased to see the positive study results of the GORE PROPATEN Vascular Graft. The long-term data for lower limb applications and the preliminary results reported for dialysis access applications are very encouraging,” said Deenu Kanjickal, PhD, Product Specialist for the GORE PROPATEN Vascular Graft. “More than 15,000 GORE PROPATEN Vascular Grafts have been successfully implanted worldwide in five years of commercial availability.”
During the meeting Gore also conducted an investigators’ meeting for the GORE PRODIGY Study which will start enrolling patients in January 2008 in the United States. The GORE PRODIGY (Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and DIsadvantaged Autologous Vein Graft for Below-Knee Arterial BYpass) Study is a prospective, randomized, multi-center study designed to demonstrate non-inferiority in patency performance of the GORE PROPATEN Vascular Graft as compared to disadvantaged autologous vein graft in a below-knee peripheral bypass application. This landmark study will provide insights into performance benchmarks of autologous veins and prosthetic bypasses. The patients will be followed-up for a period of three years and will be evaluated for several other secondary outcomes including safety, quality of life and limb salvage.
ABOUT VEITHSYMPOSIUM™
Now in its fourth decade, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The five-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. VEITHsymposium is sponsored by The Cleveland Clinic, Cleveland, Ohio.
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 25 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 and sutures for use in vascular, cardiac and general surgery. Gore was recently named the tenth best company to work for in America by Fortune. http://www.goremedical.com
GORE and PROPATEN are trademarks of W. L. Gore & Associates. AL0756-EN1 December 2007
Source: W. L. Gore
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