Clinical Study Approved for Gore Excluder Conformable AAA Endoprosthesis in United States and Japan

June 16, 2015—Gore & Associates announced that the US Food and Drug Administration has consented to the initiation of a clinical study for the new Gore Excluder Conformable abdominal aortic aneurysm (AAA) endoprosthesis. Additionally, the company announced that the Japanese clinical trial notification for the new device was accepted by Japan’s Pharmaceuticals and Medical Devices Agency. 

Gore advised that it will conduct a clinical study in the United States and Japan to assess the safety and effectiveness of the Gore Excluder Conformable AAA endoprosthesis in treating infrarenal AAAs with challenging patient anatomy. Takao Ohki, MD, will be the principal investigator for Japan. Robert Rhee, MD, will be the principal investigator for the United States. 

The clinical trial consists of two substudies, each assessing the device for a different range of patient anatomies. The first substudy will assess the device in proximal aortic neck angles of 0º to 60º and aortic neck lengths ≥ 10 mm. The other substudy will evaluate proximal aortic neck angles of 61º to 90º and aortic neck lengths ≥ 10 mm. Key design features of this next generation of the Gore Excluder AAA endoprosthesis include increased conformability and a delivery system with angulation control.

In Gore’s press release, Dr. Ohki commented, “Extreme proximal neck anatomies are one of the main reasons why an AAA patient would not qualify for endovascular therapy. 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.” Dr. Ohki is Chairman and Professor of the Department of Surgery at Jikei University School of Medicine in Tokyo, Japan.

Dr. Rhee added, “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. 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.” Dr. Rhee is Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in New York, New York. 

According to the company, 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. This delivery system, like the Gore C3 delivery system, will offer the ability to reposition the device after initial deployment if needed to achieve optimal placement.