Healthcare Industry News:  degenerative disc disease 

Devices Surgery Orthopaedic Regulatory

 News Release - May 6, 2008

Gore Receives CE Mark for GORE PRECLUDE(R) Vessel Guard

Distinguished Seal Allows Biomaterial to Be Used Across the European Union

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) announced today it received approval to apply the CE Mark for the commercial sale of GORE PRECLUDE® Vessel Guard, the first non-biological membrane indicated as a cover for vessels following anterior vertebral surgery. This advanced biomaterial reduces the risk of potential vascular injury by providing a permanent and visible plane of dissection around the vasculature to facilitate anterior revision surgery.


“Gore is very pleased to provide the clinical community and patients in Europe with an added defense against vascular injury during an anterior vertebral revision surgery,” said Conor McCrea, product specialist at Gore. “GORE PRECLUDE Vessel Guard has been used successfully in the U.S. since 2006, and we look forward to sharing the product overseas and seeing the same across Europe.”

GORE PRECLUDE Vessel Guard enables vasculature management in patients having undergone anterior spinal surgery for degenerative disc disease, including artificial disc replacement (ADR), where scarring around the aorta, vena cava, and iliac vessels can complicate revising, repositioning, or removing a disc prosthesis.

An ideal biomaterial for intimate vessel contact and protection, GORE PRECLUDE Vessel Guard is soft and conformable with excellent handling characteristics. The tight microstructured membrane is inserted between the prosthesis and the vessels during the primary surgery. In a revision surgery, the vessels can be identified, dissected from the device and mobilized.

GORE PRECLUDE Vessel Guard has a three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene (ePTFE) microstructure preventing penetration by fibroblasts, thus minimizing vascular tissue attachment to the device, allowing safer anterior revision. GORE PRECLUDE Vessel Guard is also easy to use — an elastomeric inner layer minimizes impingement and provides the stiffness needed for accurate placement. The material may be trimmed and tailored without fraying.

The U.S. Food & Drug Administration (FDA) cleared GORE PRECLUDE Vessel Guard indicated for vessel protection in August 2006. The CE Mark is a declaration that GORE PRECLUDE Vessel Guard meets the requirements for health and safety as set forth in the European directive.

ABOUT W. L. GORE & ASSOCIATES

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 materials 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 11th consecutive year. For more information, visit http://www.goremedical.com

Products listed may not be available in all markets pending regulatory clearance. GORE, PRECLUDE®, and design are trademarks of W. L. Gore & Associates.


Source: W. L. Gore

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