Healthcare Industry News:  vascular graft 

Devices Regulatory

 News Release - January 30, 2007

Gore Receives Approval to Market GORE EXCLUDER(R) AAA Endoprosthesis in Japan

Gore implantable device offers less invasive alternative to traditional open surgery for abdominal aortic aneurysms

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) received regulatory clearance on January 22, 2007 from the Pharmaceuticals and Medical Device Agency to market its GORE EXCLUDERŽ AAA Endoprosthesis in Japan. The GORE EXCLUDER AAA Endoprosthesis is an implantable device indicated for the endovascular treatment of abdominal aortic aneurysm (AAA), a condition caused by the degenerative weakening and dilation of the abdominal aorta.

"With the regulatory clearance of the GORE EXCLUDER device, Gore welcomes the opportunity to help advance endovascular therapy of aortic diseases in Japan," said John Sininger, Leader of the Medical Products Division at Gore. "By expanding into this new market, Gore substantially increases the patient population able to benefit from less invasive alternatives to traditional open-chest treatment of AAA."

AAA is a swelling or ballooning of the abdominal aorta. If left untreated, it can rupture and result in fatality. Traditional treatment of AAA requires a large surgical incision to repair the diseased artery with a synthetic graft. Endovascular surgery to implant the GORE EXCLUDER device can prevent aneurysms from rupturing without open surgery, thereby reducing the morbidity and mortality associated with surgery.

The GORE EXCLUDER device is an endovascular graft and stent combination that seals off the aneurysm and creates a new path for the blood to flow. The GORE EXCLUDER device is inserted through a small incision in the patient's leg using a catheter-based delivery technique. Once the graft is correctly positioned in the diseased aorta, the device self-expands using radial force, which in conjunction with metal anchors, permanently secures it to the walls of the aorta.

Gore recently launched a new patient education resource intended to help provide the public with information about the causes, symptoms and available treatments for AAA. The resource, part of broader content and feature improvements to www.goremedical.com, guides visitors through a rich, television-like experience that addresses questions and concerns commonly raised by those affected by AAA.

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. For more information, please visit: http://www.goremedical.com.

GORE and EXCLUDERŽ are trademarks of W. L. Gore & Associates.


Source: W. L. Gore & Associates

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