FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) today announced that the Food and Drug Administration (FDA) has consented to the initiation of the clinical study for the new GORE® EXCLUDER® Conformable AAA Endoprosthesis and the Japanese clinical trial notification for the new device was accepted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Gore will conduct a clinical study in the US and Japan to assess the safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis in treating infrarenal abdominal aortic aneurysms (AAA) with challenging patient anatomy. The new device is the next generation of the GORE® EXCLUDER® AAA Endoprosthesis and includes several key design features, including increased conformability and a delivery system with angulation control.
Robert Rhee, MD, Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in New York, will be the principal investigator for the US, and Takao Ohki MD, PhD, Chairman and Professor of the Department of Surgery at Jikei University School of Medicine in Tokyo, will be the principal investigator for Japan.
“Extreme proximal neck anatomies are one of the main reasons why a AAA patient would not qualify for endovascular therapy,” said Dr. Ohki. “The new GORE EXCLUDER Conformable AAA Endoprosthesis 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 10 mm or greater. The other sub-study will evaluate proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10 mm or greater. Once approved, the GORE EXCLUDER Conformable AAA Endoprosthesis would be the only device indicated for aortic neck angles up to 90 degrees and aortic neck lengths as short as 10 mm.
The GORE EXCLUDER Conformable AAA Endoprosthesis 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 maximize the conformability of the device. Like the GORE® C3® Delivery System, the GORE EXCLUDER Conformable AAA Endoprosthesis delivery system will offer the ability to reposition the device after initial deployment if needed to achieve optimal device placement.
“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 Dr. Rhee. “The GORE EXCLUDER Conformable Device delivery system is designed to give physicians a greater level of control over device placement to maximize device conformability regardless of anatomic challenges.”
The GORE EXCLUDER Conformable AAA Endoprosthesis builds on the proven clinical performance of the GORE EXCLUDER AAA Device, which has 17 years of worldwide experience and more than 215,000 devices distributed, a history unmatched by currently available AAA endografts.
“We’ve 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.”
Gore has met several other key milestones in its commitment to providing the most complete portfolio of products intended to durably treat the aorta. Most recently, enrollment in the GORE® EXCLUDER® Iliac Branch Clinical Study was completed and the first patient was enrolled in the GORE® TAG® Thoracic Branch Endoprosthesis Early Feasibility Study, which will assess the treatment of aortic arch aneurysms. In 2014, Gore initiated a clinical study evaluating the use of the same device for the treatment of thoracic aortic aneurysms that require coverage of the left subclavian artery (LSA). Gore also enrolled its first patients in the Gore Thoracoabdominal Aortic Aneurysm Clinical Study, which will assess the durable repair of aortic aneurysms encroaching on or involving visceral branch vessels using the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis.
About W. L. Gore & Associates
At Gore, we have provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US “100 Best Companies to Work For” lists since the rankings debuted in 1984. For more information, visit www.goremedical.com.
Products listed may not be available in all markets. GORE®, C3®, EXCLUDER®, and TAG® are trademarks of W.L. Gore & Associates.