CE Marking Means Gore Has Endovascular Treatment Option for Iliac Artery Aneurysms

W. L. Gore & Associates has gained CE Mark approval for its GORE EXCLUDER Iliac Branch Endoprosthesis. The company says Excluder is the first complete, fully engineered system intended for endovascular treatment of common iliac artery aneurysms or aorto-iliac aneurysms.

Background

The EXCLUDER Iliac Branch Endoprosthesis is built on Gore’s proven technology platform and designed using the same durable, expanded polytetrafluoroethylene (ePTFE) graft. It is designed for use 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.

The 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 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.

Physician comments

“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.”

Company comments

“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 news of Gore’s Excluder CE marking comes in the same week in which the 25 cm Gore® VIABAHN® Endoprosthesis gained US FDA approval. Viabahn possesses a Heparin Bioactive Surface for the treatment of symptomatic peripheral arterial disease lesions in the Superficial Femoral Artery (SFA) and at 25cm the newly approved iteration is the longest length stent-graft available. It is designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.  Find Gore’s Viabahn Press Release here.

Source: W.L. Gore and Associates, Business Wire