FDA Advisory Committee Votes in Favor of Cardinal Health’s InCraft AAA Stent Graft System
June 13, 2018—Cardinal Health, Inc. announced that the US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has provided a favorable recommendation on the premarket approval application of the company's InCraft abdominal aortic aneurysm (AAA) stent graft system, an endovascular aneurysm repair (EVAR) technology for the treatment of infrarenal AAAs. The FDA panel voted 11 to 4 in favor of the benefits of the InCraft system.
The InCraft system is an ultra-low-profile and flexible stent graft system designed to prevent rupture of infrarenal AAAs in a wide range of patient populations. The company noted that although several EVAR devices are currently available in the United States, treatment options are limited for many AAA patients with small femoral or iliac arteries or with heavily calcified or tortuous vessels that could lead to complications during the introduction of EVAR devices.
According to the company the favorable vote of the advisory committee followed a review of clinical data from the pivotal INSPIRATION trial, a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the InCraft system in patients with AAA.
The trial showed that the InCraft system met the primary safety and effectiveness endpoints, with a low rate of major adverse events at 30 days and a high rate of successful aneurysm treatment at 1 year. The INSPIRATION data presented at the Circulatory System Devices Panel meeting demonstrated high survival of approximately 80% and no aneurysm ruptures through 4 years of follow-up.
The InCraft system, which received European CE Mark approval in 2014, is commercially available in 39 countries. In the United States, the InCraft system is an investigational device and is not available for sale, advised Cardinal Health.