Enrollment Begins for Study of Gore's Excluder Conformable AAA Endoprosthesis With Active Control System
January 3, 2018—Gore & Associates announced the first implantation in the United States of the its Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system for endovascular aneurysm repair (EVAR). The procedure was performed by Robert Rhee, MD, Chief of Vascular and Endovascular Surgery at Maimonides Medical Center in New York, New York.
According to the company, the Excluder conformable AAA device included the Active Control system for use in the abdominal aorta. The delivery system includes angulation control and, additionally, the Active Control system offers the ability to reposition the device if needed after initial deployment to achieve optimal device placement.
Dr. Rhee is National Principal Investigator of this US Food and Drug Administration–approved clinical study that will assess the safety and effectiveness of the device in treating infrarenal AAAs in patients with challenging anatomy. The study consists of two substudies, each assessing the device for a different range of patient anatomies. The implantation by Dr. Rhee is part of the short neck substudy to assess the device in aortic neck angles of 0º to 60º and aortic neck lengths ≥ 10 mm. The high neck angulation substudy will evaluate proximal aortic neck angles of 61º to 90º and aortic neck lengths ≥ 10 mm.
In Gore's announcement, Dr. Rhee commented, “Patients with extreme proximal neck anatomies often do not qualify for EVAR. Regardless of device flexibility, current delivery systems make it difficult to achieve conformability during deployment. The angulation control in the new delivery system for the Gore Excluder conformable AAA device is intended to allow physicians a greater level of control to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen.”