CE Mark For Range Extensions To Gore’s Excluder AAA Endoprosthesis

In short

W. L. Gore & Associates, Inc. has gained CE Mark for the new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components of the Gore® Excluder® AAA Endoprosthesis. The company says the availability of these new components provides physicians with a proven and durable endovascular option to treat abdominal aortic aneurysms (AAAs) in patients with an infrarenal aortic inner neck diameter range of 30 to 32 mm, which expands the overall treatment range to 19-32 mm.

Background

The Gore Excluder AAA Endoprosthesis is an endovascular stent-graft that seals off the aneurysm and creates a new path for blood flow. The device is inserted through a small incision in the patient’s leg using a catheter-based delivery technique. Once the physician has positioned the graft in the diseased aorta, the Gore® C3® Delivery System uniquely and intuitively enables repositioning of the stent-graft. The ability to reposition the device is designed to minimise complications that could occur if the graft needs to be moved after the initial deployment.

The new large diameter components represent the first products in Gore’s innovative portfolio to reduce access vessel requirements. Compatible with an 18 Fr Gore® DrySeal Sheath, the new 35 mm trunk-ipsilateral leg and 36 mm aortic extender represent one of the lowest profiles for treating infrarenal aortic necks measuring up to 32 mm in diameter.

Physician comments

“Having a wide range of sizing options available for various anatomies simplifies the decision making for interventionalists. This new size allows more patients with large aortic neck diameters to benefit from endovascular treatment,” said Dr. Mo Hamady, Consultant Interventional Radiologist at St. Mary’s Hospital, London.

Company comments

“By expanding our sizing options to include larger anatomies, Gore now offers a complete range of sizes to treat differing anatomies with the preferred infrarenal placement,” said Ryan Takeuchi, Gore Aortic Business Leader. “Gore strives to provide superior performance through design. Our extended AAA sizing portfolio and innovative delivery solution simplifies the EVAR procedure for physicians and patients alike.”

Source: W L Gore & Associates, Inc., Business Wire