Gore & Associates has received EU’s approval to market its PRECLUDE vessel guard, developed to provide protection for vasculature following anterior spinal surgery for degenerative disc disease, just in case if these surgical patients have to return for a revision procedure. Anterior vertebral re-explorations have inherently increased risks of damage to major abdominal vessels, such as the aorta, the vena cava, and the iliacs.
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.
Press release: Gore Receives CE Mark for GORE PRECLUDE® Vessel Guard
Video (Windows Media): 14-Month Revision Surgery with a GORE ePTFE Membrane