02.05.14
The U.S. Food and Drug Administration (FDA) has approved W.L. Gore & Associates' Viabahn Endoprosthesis to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access (AV access) grafts.
“I have confidence in the Gore Viabahn Endoprosthesis,” said Thomas Vesely, M.D., interventional radiologist at the Vascular Access Center in Frontenac Grove, Mo. “The device can be precisely deployed and its flexibility allows placement across the elbow and other challenging venous anastomotic locations. I can rapidly and accurately deploy a Gore Viabahn device in an emergent situation, and it will provide effective treatment for stenosis at the venous anastomosis of AV access grafts. The IDE approval study showed the Gore Viabahn device provides longer primary patency when compared to repeated angioplasty for these lesions.”
In the REVISE Clinical Study (AVR 06-01), the Gore Viabahn device group demonstrated statistical superiority of target lesion primary patency as compared to PTA (p = 0.008).
The Gore Viabahn Endoprosthesis device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure. The ePTFE luminal surface of the Viabahn Endoprosthesis incorporates the Carmeda BioActive Heparin Surface. This proprietary end-point covalently bonded heparin technology is anchored to the graft surface and is intended to provide sustained thromboresistance.
“We are pleased to expand the Gore Viabahn Endoprosthesis to hemodialysis access,” said Ray Swinney, business unit leader for the Gore Peripheral Interventional Business Unit.
The Gore Medical Products Division has provided therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million Gore medical devices have been implanted, according to the company. The 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.
W.L. Gore & Associates is headquartered in Flagstaff, Ariz.
“I have confidence in the Gore Viabahn Endoprosthesis,” said Thomas Vesely, M.D., interventional radiologist at the Vascular Access Center in Frontenac Grove, Mo. “The device can be precisely deployed and its flexibility allows placement across the elbow and other challenging venous anastomotic locations. I can rapidly and accurately deploy a Gore Viabahn device in an emergent situation, and it will provide effective treatment for stenosis at the venous anastomosis of AV access grafts. The IDE approval study showed the Gore Viabahn device provides longer primary patency when compared to repeated angioplasty for these lesions.”
In the REVISE Clinical Study (AVR 06-01), the Gore Viabahn device group demonstrated statistical superiority of target lesion primary patency as compared to PTA (p = 0.008).
The Gore Viabahn Endoprosthesis device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure. The ePTFE luminal surface of the Viabahn Endoprosthesis incorporates the Carmeda BioActive Heparin Surface. This proprietary end-point covalently bonded heparin technology is anchored to the graft surface and is intended to provide sustained thromboresistance.
“We are pleased to expand the Gore Viabahn Endoprosthesis to hemodialysis access,” said Ray Swinney, business unit leader for the Gore Peripheral Interventional Business Unit.
The Gore Medical Products Division has provided therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million Gore medical devices have been implanted, according to the company. The 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.
W.L. Gore & Associates is headquartered in Flagstaff, Ariz.
The Gore Medical Products Division has provided therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore medical devices have been implanted, according to the company. The 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. W.L. Gore & Associates is headquartered in Flagstaff, Ariz. - See more at: http://www.mpo-mag.com/contents/view_breaking-news/2014-01-27/gore-c3-delivery-system-approved-in-japan/#sthash.zEufqw6Q.dpuf
The Gore Medical Products Division has provided therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore medical devices have been implanted, according to the company. The 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. W.L. Gore & Associates is headquartered in Flagstaff, Ariz. - See more at: http://www.mpo-mag.com/contents/view_breaking-news/2014-01-27/gore-c3-delivery-system-approved-in-japan/#sthash.zEufqw6Q.dpuf