The US Food and Drug Administration (FDA) has consented to the initiation of the clinical study for the new Gore Excluder conformable abdominal aortic aneurysm endoprosthesis, and the Japanese clinical trial notification for the new device was accepted by Japan’s Pharmaceuticals and Medical Devices Agency.
Gore will conduct a clinical study in the USA and Japan to assess the safety and effectiveness of the endoprosthesis in treating infrarenal abdominal aortic aneurysms with challenging patient anatomy. The new device is the next generation of the Excluder endoprosthesis and includes several key design features, including increased conformability and a delivery system with angulation control.
Robert Rhee, chief of vascular and endovascular surgery at Maimonides Medical Center in New York,, will be the principal investigator in the USA, and Takao Ohki chairman and professor of the Department of Surgery at Jikei University School of Medicine in Tokyo, will be the principal investigator in Japan.
“Extreme proximal neck anatomies are one of the main reasons why an abdmonial aortic aneurysm patient would not qualify for endovascular therapy,” said Ohki. “The new Gore Excluder will provide a minimally invasive treatment option for patients in this situation, some of whom are unfit for open surgery. For these patients, this device may be their only treatment option.”
The clinical trial consists of two sub-studies, each assessing the device for a different range of patient anatomies. The first sub-study will assess the device in proximal aortic neck angles of zero to 60 degrees and aortic neck lengths of 10mm or greater. The other sub-study will evaluate proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10mm or greater. Once approved, the endoprosthesis would be the only device indicated for aortic neck angles up to 90 degrees and aortic neck lengths as short as 10mm.
The Excluder is deployed via an enhanced delivery system that includes angulation control, giving physicians the option to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen and to maximise the conformability of the device. Like the Gore C3 delivery system, the Excluder delivery system will offer the ability to reposition the device after initial deployment if needed to achieve optimal device placement, a company press release says.
“Even if a device is flexible enough to accommodate a highly angulated aortic neck, achieving conformability during deployment with current delivery systems can be difficult,” said Rhee. “The Excluder delivery system is designed to give physicians a greater level of control over device placement to maximise device conformability regardless of anatomic challenges.”
The device builds on the proven clinical performance of the Excluder abdominal aortic aneurysm device, which has 17 years of worldwide experience and more than 215,000 devices distributed, a history unmatched by currently available abdominal aortic aneurysm endografts.
“We have combined a novel stent design, device conformability, and an enhanced delivery system to give physicians even more control during the procedure,” said Ryan Takeuchi, aortic business unit leader at Gore. “We feel this combination is critically important to effectively expand the treatable population, affording more patients the benefits of endovascular therapy. We are eager to begin this clinical study in both the US and Japan.”