Gore AVIATOR Study Receives Conditional Approval from FDA.FLAGSTAFF Flagstaff, city (1990 pop. 45,857), seat of Coconino co., N Ariz., near the San Francisco Peaks; inc. 1894. Lumbering, ranching, and a lively tourist trade thrive in the region, where many ruined pueblos, numerous state parks, several lakes, and large pine forests , Ariz. -- Conditional approval to proceed with the AVIATOR (Angioplasty vs. GORE VIABAHN[R] Endoprosthesis Treatment Of GRaft Stenosis) Study was announced today by W. L. Gore & Associates (Gore). The AVIATOR Study is a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , multi-center clinical trial intended to establish efficacy and safety of the GORE VIABAHN[R] Endoprosthesis with PROPATEN Bioactive Surface to revise arterio-venous grafts at the venous anastomosis anastomosis /anas·to·mo·sis/ (ah-nas?tah-mo´sis) pl. anastomo´ses [Gr.] 1. communication between vessels by collateral channels. 2. in hemodialysis patients. The study will randomize ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. patients to the GORE VIABAHN[R] Endoprosthesis and to percutaneous transluminal transluminal /trans·lu·mi·nal/ (trans-loo´mi-n'l) through or across a lumen, particularly of a blood vessel. trans·lu·min·al adj. Passing or occurring across a lumen. angioplasty (PTA PTA or parent-teacher association: see parent education. ). Tom Vesely, MD, Medical Director on the AVIATOR Study and an Interventional Radiologist at Vascular Access Center of Frontenac Grove, MO, states, "The study is designed to demonstrate the clinical benefit of using a stent-graft for AV graft revisions, rather than PTA alone." Vesely continues, "With a focus on target-lesion primary patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. , the study is designed to show an increased amount of time between interventions in dialysis access grafts." The GORE VIABAHN[R] Endoprosthesis devices used in the AVIATOR study will feature the proprietary end-point covalent bonding of heparin, similar to the recently launched GORE PROPATEN Vascular Graft used in AV access. "We are excited to include this latest advance in the GORE VIABAHN[R] Product line, the GORE VIABAHN[R] Endoprosthesis with PROPATEN Bioactive Surface, in the study," states Melissa Brookshier, M.S., Gore Product Specialist. "We anticipate study enrollment to begin in early Fall, 2007." The GORE VIABAHN[R] Endoprosthesis with PROPATEN Bioactive Surface is constructed with a durable, biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. , expanded polytetrafluoroethylene (ePTFE) liner with a proprietary covalently bonded heparin surface, reinforced with an external nitinol stent structure. Worldwide, more than 70,000 GORE VIABAHN[R] Endoprostheses have been implanted. 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 23 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 by Fortune magazine. Products listed may not be available in all markets pending regulatory clearance. GORE, PROPATEN and VIABAHN[R] are trademarks of W. L. Gore & Associates. |
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