Excluder iliac branch endoprosthesis receives the CE mark

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Gore has 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 the CE mark.

The first patient procedures in Europe were successfully completed by vascular surgeons Piergiorgio Cao, chief of Vascular Surgery at San Camillo Hospital, Rome, Italy, Mo Hamady, consultant interventional radiologist at St Mary’s Hospital, London, UK, and Michael Jenkins, consultant vascular surgeon and clinical lead at St Mary’s Hospital, London, UK.

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 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 bifemoral delivery system,” said Hamady.

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

The Excluder iliac branch endoprosthesis system provides a treatment range of 6.5–13.5mm for the internal iliac arteries, and a treatment range of 6.5–25mm for the external iliac arteries. The delivery profile of the loaded catheter allows the use of a 16F introducer sheath for the iliac branch component, and a 12F 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.”

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