Gore Receives Approval To Market GORE EXCLUDER(R) AAA Endoprosthesis And GORE TAG(R) Thoracic Endoprosthesis In Canada

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Medical Devices / Diagnostics
Article Date: 20 Nov 2008 - 9:00 PDT

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W. L. Gore & Associates (Gore) today announced at the 35th annual VEITHsymposium™ in New York that it has received regulatory clearance from Health Canada's Therapeutic Products Directorate to market the GORE EXCLUDER AAA Endoprosthesis and GORE TAG Thoracic Endoprosthesis in Canada. Planning is underway for Canadian physician training on the devices, and the subsequent commercial product release timeline will be announced in the near future. The GORE EXCLUDER AAA Endoprosthesis and the GORE TAG Thoracic Endoprosthesis devices are the leading options for less invasive treatment of abdominal aortic aneurysm (AAA) and thoracic aortic aneurysm (TAA) in North America. The GORE EXCLUDER AAA Endoprosthesis and the GORE TAG Thoracic Endoprosthesis were previously granted regulatory approval in the US, Europe, Japan and South Korea.

The GORE EXCLUDER AAA Endoprosthesis is an implantable device indicated for the endovascular treatment of AAA, a condition caused by the degenerative weakening and dilation of the abdominal aorta. If left untreated, it can rupture and result in fatality. The GORE TAG Thoracic Endoprosthesis is an implantable device used to treat TAA, or an aneurysm of the descending thoracic aorta, the body's main circulatory vessel. TAA is a life-threatening condition generally believed to be significantly under-diagnosed, and patients with TAA are at risk of death due to internal bleeding resulting from a ruptured aorta.

Until recently, treatment for AAA and TAA required invasive, large incision surgery and a lengthened hospital stay to repair the diseased or damaged artery. With the GORE EXCLUDER AAA Endoprosthesis and the GORE TAG Thoracic Endoprosthesis, aneurysms can be prevented from rupturing through a minimally invasive procedure, thereby reducing the hospital stay, morbidity and mortality associated with surgery.

"Gore is pleased to expand its international efforts to improve patient care for both AAA and TAA, with less invasive treatment alternatives for the Canadian patient population," said John Sininger, Leader of the Gore Medical Products Division. "The GORE EXCLUDER Device and the GORE TAG Device have already proven to be valuable alternatives to invasive open surgery elsewhere, and Gore welcomes the opportunity to advance less invasive endovascular therapies for aortic diseases in Canada."

The GORE EXCLUDER AAA Endoprosthesis 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 AAA Endoprosthesis 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 and metal anchors to permanently secure it to the walls of the aorta.

The GORE TAG Thoracic Endoprosthesis is a thoracic endoprosthesis that internally relines the thoracic aorta and isolates the diseased segment from blood circulation. The GORE TAG Thoracic Endoprosthesis is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient's groin.

About Veithsymposium™

Now in its fourth decade, VEITHsymposium™ provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features over 400 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. Press registration details can be found at http://www.VEITHpress.org or contact Pauline T. Mayer at 631.979.3780 or e-mail ptm@ptmhcm.com. VEITHsymposium™ is sponsored by Cleveland Clinic (Cleveland, OH).

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 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.

GORE, EXCLUDER®, TAG®, and designs are trademarks of W. L. Gore & Associates.

Gore & Associates