Healthcare Industry News:  abdominal aortic aneurysm 

Devices Interventional Regulatory

 News Release - June 5, 2008

Gore Receives Approval to Market GORE TAG(R) Thoracic Endoprosthesis in Japan

Expedited Clearance Provides Less Invasive Treatment Alternative for Thoracic Aortic Aneurysms

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates, Inc. (Gore) announced today that it has received regulatory clearance from the Pharmaceuticals and Medical Device Agency (PMDA), to market the GORE TAG® Thoracic Endoprosthesis in Japan. The GORE TAG Device is used to treat aneurysms of the descending thoracic aorta, the largest artery in the body. The GORE TAG Device was designated as the highest priority device for expedited PMDA review by the various physician societies in Japan. The GORE TAG Device, the first approved thoracic stent-graft in the United States, was approved for use in the U.S. in March of 2005.

Patients with a thoracic aortic aneurysm are at risk of death due to internal bleeding resulting from a rupture of their aorta. Traditional treatment of these aneurysms requires open surgery and a large surgical incision to repair the diseased artery with a synthetic graft. Due to the high morbidity and mortality rates and significant impact on quality of life associated with open surgical repair of thoracic aortic disease and injury, less-invasive procedures using endovascular stent-grafts have been developed and evaluated in clinical studies over the last decade.

The GORE TAG Device, an extremely flexible ePTFE graft with an outer self-expanding nitinol support structure, internally relines the aorta and isolates the diseased segment from blood circulation. The device is inserted by employing a minimally invasive catheter delivery technique through a small incision in the patient’s groin. In the GORE TAG Device Pivotal Study comparing the GORE TAG Thoracic Endoprosthesis to standard open surgical repair, patients treated with the endoprosthesis experienced fewer complications, significantly less procedural blood loss, shortened hospital stays, and a two times faster return to normal activity than those treated with open surgery. Additionally, through five years of follow-up, patients treated with the GORE TAG Device have a significantly lower incidence of major adverse events and improved aneurysm-related survival versus patients treated with open surgery. Through 2007, approximately 25,000 GORE TAG Devices have been distributed worldwide.

The first post-PMDA approval procedure using the GORE TAG Endoprosthesis was conducted by Toru Kuratani, M.D. at Osaka University in Japan, and was supported by Takao Ohki, M.D., who has a significant amount of experience with the device. The procedure went very smoothly and took approximately one hour to complete. “The GORE TAG Thoracic Endoprosthesis offers tremendous potential for patients affected with an aortic aneurysm because it prevents an aneurysm from rupturing and reduces the morbidity and mortality associated with open surgery. The expedited approval of the GORE TAG Device underscores the understanding and appreciation of the Japanese clinical community for bringing endovascular treatments to the patient population,” said John Sininger, Leader of the Gore Medical Products Division.

Gore received regulatory clearance in January 2007 from the PMDA to market its GORE EXCLUDER® AAA Endoprosthesis in Japan for the endovascular treatment of abdominal aortic aneurysms (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 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 meshes 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®, and TAG® are trademarks of W. L. Gore & Associates.


Source: W. L. Gore

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