FDA Advisory Committee recommends premarket approval for Incraft AAA Stent Graft System for infrarenal abdominal aortic aneurysms. - Cordis/Cardinal Health.

Cardinal Health announced that the 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 . 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. 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 U.S. 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.

The Incraft system received a CE mark in 2014, is commercially available in 39 countries.