Healthcare Industry News:  Meda AB 

Devices Regulatory

 News Release - December 10, 2014

Gore Receives CE Mark Approval for GORE(R) VIABAHN(R) Endoprosthesis for Revision of Arteriovenous Access

Flexibility and Durability to Aid Hemodialysis Patients

FLAGSTAFF, Ariz.--(Healthcare Sales & Marketing Network)--W. L. Gore & Associates, Inc. (Gore) today announced that the GORE® VIABAHN® Endoprosthesis has received CE Mark approval to improve blood flow in symptomatic obstruction of peripheral veins, excluding the venae cavae and pulmonary veins.

“The GORE VIABAHN Endoprosthesis is a welcome addition to options available for treating stenosis in the dialysis access circuit,” said Peter Riley, MD, Consultant Interventional Radiologist at the Queen Elizabeth Hospital Birmingham, United Kingdom. “It has a proven track record in maintaining patency in central chest vein stenosis as confirmed by our recently published single-center study. It is extremely flexible, allowing deployment across anatomical sites of movement and flexion. The Gore REVISE Clinical Study indicates improved patency compared to PTA in the graft to vein anastamosis and has demonstrated similar outcomes to draining veins, particularly at the cephalic arch, in my practice.”

In the Gore 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).

With a long history of iliac and superficial femoral artery use, the GORE VIABAHN Device is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available. It 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 GORE VIABAHN Endoprosthesis incorporates the CBAS® Heparin Surface. This heparin technology consists of a proprietary, covalent end-point attachment to the graft surface that is intended to provide sustained thromboresistance.

“We are pleased to expand the GORE VIABAHN Endoprosthesis to hemodialysis access in Europe,” said Ray Swinney, Business Unit Leader for the Gore Peripheral Interventional Business Unit. “We are committed to exceeding the expectations of vascular surgeons, interventional radiologists, and interventional nephrologists who have been seeking a better solution for their dialysis access patients.”

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative 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, 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 is one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984. For more information, visit www.goremedical.com.

GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. CBAS® is a trademark of CarMeda AB, a wholly owned subsidiary of W. L. Gore & Associates.


Source: W. L. Gore

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