Gore has announced the first implant of the Gore Excluder Conformable abdominal aortic aneurysms (AAA) endoprosthesis in the USA. The procedure took place on 19 December, 2017 at Maimonides Medical Center in New York, USA by Robert Rhee, chief of Vascular and Endovascular Surgery, and national principal investigator.
This endovascular aortic repair (EVAR) device, which is the first to feature angulation control, is part of an investigational clinical study approved by the US Food and Drug Administration (FDA). The clinical study will assess the safety and effectiveness of the device in treating infrarenal AAA in patients with challenging anatomy. The clinical study consists of two sub-studies, each assessing the device for a different range of patient anatomies. The implantation by Rhee is part of the short neck sub-study to assess the device in aortic neck angles of 0 to 60 degrees and aortic neck lengths of 10 mm or greater. The high neck angulation sub-study will evaluate proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10 mm or greater.
“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,” says Rhee. “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.”
The Gore Excluder Conformable AAA device builds on the clinical performance of the Gore Excluder device, with 20 years of worldwide experience and more than 300,000 patients treated. The new device leverages the limb design of the Gore Excluder device which has demonstrated 0.5% limb occlusion through 3-year follow-up. The limbs, a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent, are designed to prevent kinking and occlusion.
The Gore Excluder Conformable AAA device debuts the company’s Active Control system into the abdominal aorta. This delivery system 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 and seal of the device. Like the Gore C3 Delivery system, the Gore Active Control system offers the ability to reposition the device if needed after initial deployment to achieve optimal device placement.
“In collaborating with our physician partners, we heard that highly angulated anatomy can challenge the ability of currently available EVAR devices to achieve an optimal seal”, says Eric Zacharias, vascular business leader at Gore. “The IDE study will evaluate the ability of the system to fill the unmet need for an EVAR device to treat that anatomy. The system combines the nesting stent design proven successful in the Conformable Gore Tag Thoracic Endoprosthesis with the repositionability of the GORE C3 Delivery system, while the new angulation control feature meets the need for an EVAR device that can treat more challenging anatomies.”