Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial

W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study.

The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee.

“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,” Dr. Rhee said in a prepared statement.

Gore touts the Excluder EVAR device as the first to feature angulation control, and said the trial will look to explore the safety and effectiveness of the device for treating infrarenal abdominal aortic aneurysms in patients with challenging anatomies.

The clinical study consists of two sub-studies which look to assess the device for different patient anatomies, with the initial procedure acting as part of the short neck sub-study to assess the device in patients with aortic neck angles of between 0 and 60 degrees and aortic neck lengths of 10 mm or greater.

The second high neck angulation sub-study will evaluate the device in patients with aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10mm or greater.

“This implant is the latest step in our continuing efforts to offer the broadest and most technically advanced endovascular treatment capabilities on the market. Since bringing our first EVAR device to market two decades ago, Gore has been committed to providing innovative solutions that expand the endovascular treatment of aortic disease. 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. 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,” Gore vascular biz leader Eric Zacharias said in a press release.

Last May, Gore said it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region.

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