USFDA Advisory Committee Votes for Cardinal Health’s INCRAFT AAA Stent Graft System

Cardinal Health 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 for INCRAFT AAA Stent Graft System (INCRAFT). The panel voted 11 to 4 in favor of the benefits of the INCRAFT system. The INCRAFT system is an advanced endovascular aneurysm repair (EVAR) technology for the treatment of infrarenal abdominal aortic aneurysms (AAAs), a severe and complex condition. “We are pleased with the panel’s recommendation today, which brings us one step closer to making the INCRAFT system available for thousands of high-risk patients in the US,” said Dr Shaden Marzouk, chief medical officer at Cardinal Health. “We appreciated the opportunity to present our data supporting the INCRAFT system and look forward to continuing discussions with the FDA to bring this technology to doctors and patients.”

An abdominal aortic aneurysm is a bulging, weakened area in the wall of the lower part of the aorta, the main artery of the body, which, unless treated, can rupture and lead to a life-threatening hemorrhage. An estimated 1.5 million people in the United States have AAA, and more than 200,000 new diagnoses are made each year. These aneurysms account for approximately 10,000 deaths annually in the US. Once identified, treatment options for AAAs include medical monitoring, open surgical repair, or EVAR, a minimally invasive endovascular treatment option with the potential to reduce perioperative mortality and morbidity. While several EVAR devices are currently available in the US, 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. 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 population.

The favorable vote of the advisory committee followed a review of clinical data from the pivotal INSPIRATION trial, a prospective, multi-center, 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 year³. As presented at the Circulatory System Devices Panel meeting earlier today, the trial demonstrated high survival of nearly 80 percent and no aneurysm ruptures through 4 years of follow up. The INCRAFT system, which received a CE mark in 2014, is commercially available in 39 countries. The INCRAFT system is an investigational device not available for sale in the United States. – Medical Buyer Bureau