Australian Approval for GORE® EXCLUDER Iliac Branch Endoprosthesis

W. L. Gore & Associates has seen its GORE® EXCLUDER® Iliac Branch Endoprosthesis gain Australian approval (TGA), making it the first complete, fully engineered system for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

Background

Gore’s new Iliac Branch Endoprosthesis is part of its suite of EXCLUDER products, developed to address multiple aortic aneurysm anatomies through minimally invasive means.

The new device is intended for use 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. It is built on Gore’s long-established technology platform and designed using the same durable, expanded polytetrafluoroethylene (ePTFE) graft.

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 first patient procedures in Australia were successfully completed by vascular surgeons Dr. Steven Dubenec, Head of Department of Vascular Surgery at Royal Prince Alfred Hospital, Sydney, and Dr. Jack Loa, at Macquarie University Hospital, Sydney.

Physician comments

“Based on the design of the GORE® EXCLUDER® Device, this system provides a wide treatment range and long-term durability, which is extremely important for optimal clinical success,” said Dr. Dubenec. “The pre-cannulated branch and bi-femoral delivery elements of the GORE EXCLUDER Iliac Branch Endoprosthesis support the ease of use of this device.”

Company comments

“This new, fully engineered system builds off the trusted performance of the GORE EXCLUDER AAA Endoprosthesis, providing physicians with a minimally invasive treatment option for iliac repair,” said Ryan Takeuchi, Gore Aortic Business Leader. “We have made great strides in advancing our GORE EXCLUDER Device and branch endoprosthesis portfolio and remain committed to making these innovative devices available to more patients across the world.”

Source: Business Wire

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