W. L. Gore & Associates (Gore) has received approval from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to start clinical trial of the new Excluder Conformable AAA Endoprosthesis device.
The company will carry out clinical trial in both countries to evaluate the safety and effectiveness of the Gore Excluder Conformable AAA Endoprosthesis in treating infrarenal abdominal aortic aneurysms (AAA) with challenging patient anatomy.
New York Maimonides Medical Center vascular and endovascular surgery chief Dr Robert Rhee will be the principal investigator for the US trial, while Tokyo Jikei University School of Medicine department of surgery professor and chairman Dr Takao Ohki will be the principal investigator for the study in Japan.
Dr Ohki said: "Extreme proximal neck anatomies are one of the main reasons why a AAA patient would not qualify for endovascular therapy."
The trial includes two sub-studies, each evaluating the device for a different range of patient anatomies.
The first sub-study will evaluate the device in proximal aortic neck angles of zero to 60 degrees and aortic neck lengths of 10mm or greater, while the other sub-study will assess proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10mm or greater.
Gore Excluder Conformable AAA Endoprosthesis is said to deploy through an enhanced delivery system that comprises angulation control, providing physicians the option to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen and to maximize the conformability of the device.
Image: The Gore Excluder Conformable AAA Endoprosthesis device is designed to bring endovascular therapy options to patients previously considered untreatable. Photo: courtesy of Business Wire / W. L. Gore & Associates, Inc.