GORE® EXCLUDER® Iliac Branch Endoprosthesis Is First Dedicated System of Its Kind Approved in Europe

First Successful Implants Completed in Italy and the United Kingdom, Providing Endovascular Repair to Iliac Arteries

Flagstaff, Ariz. (November 7, 2013) — W. L. Gore & Associates (Gore) today announced the GORE® EXCLUDER® Iliac Branch Endoprosthesis, the first complete, fully engineered system (Gore designed iliac branch and internal iliac components) intended for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, has received CE Mark. The first patient procedures in Europe were successfully completed by vascular surgeons Piergiorgio Cao, MD, Chief of Vascular Surgery at San Camillo Hospital, Rome, Italy, Mo Hamady, MD, Consultant Interventional Radiologist at St. Mary’s Hospital, London, and Mr. Michael Jenkins, Consultant Vascular Surgeon and Clinical Lead at St. Mary’s Hospital, London.

This new device — used in conjunction with GORE® EXCLUDER® AAA Endoprosthesis components to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries — is built on Gore’s proven technology platform and designed using the same durable, expanded polytetrafluoroethylene (ePTFE) graft.

"Gore’s dedicated components for iliac artery repair provide the first complete low profile system for managing common iliac artery aneurysms. The procedure is simple and straightforward due to the pre-cannulated branch and bi-femoral delivery system," said Dr. Hamady.

"In endovascular procedures involving iliac arteries, this device is easy to handle and repositionable for precise placement. The GORE® EXCLUDER® Device based design also provides a wide treatment range and long-term durability, which is extremely important for optimal success," said Prof. Cao. "Additionally, the low profile delivery provides for enhanced vessel access, benefiting patients and physicians alike."

The GORE EXCLUDER Iliac Branch Endoprosthesis system provides a treatment range of 6.5-13.5 mm for the internal iliac arteries, and a treatment range of 6.5-25 mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16 Fr introducer sheath for the iliac branch component, and a 12 Fr flexible, reinforced introducer sheath for the internal iliac component.

"The new GORE EXCLUDER Iliac Branch Endoprosthesis offers physicians a fully engineered system that enables the best possible patient care and fulfills an unmet clinical need," said Ryan Takeuchi, Gore Aortic Business Leader. "This new product reflects the needs of today’s vascular surgeons, and is driven by Gore’s commitment to delivering innovation by design."

The GORE EXCLUDER Iliac Branch Endoprosthesis is part of the growing family of GORE EXCLUDER Device products that share a mission to effectively treat aortic aneurysms through minimally invasive means, backed by Gore’s highly rated clinical support team and comprehensive educational offerings.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 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 is one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984.

Products listed may not be available in all markets. GORE®, EXCLUDER®, and designs are trademarks of W. L. Gore & Associates. AS1042-EU2 NOVEMBER 2013

 

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