Cardinal Health Inc.'s stent-graft system was recommended by a U.S. Food and Drug Administration panel for use in heart surgery.
The stent system, called Incraft AAA Stent Graft System, is meant to treat infrarenal abdominal aortic aneurysms, or AAA — a weakened area in the aorta, the body's main artery, which can rupture and lead to a life-threatening hemorrhage if left untreated. AAA causes about 10,000 deaths in the U.S. every year.
Dublin, Ohio-based Cardinal Health said that while there are devices similar to Incraft already available, its ultra low-profile device is meant for AAA patients with small femoral or iliac arteries or with heavily calcified or tortuous vessels that could lead to complications during treatment.
The FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 11-4 in favor of the Incraft system's approval. The device is commercially available in 39 countries, not including the U.S.
Cardinal Health's premarket approval application for Incraft is supported by data from a successful study, called Inspiration, where the survival rate after four years was nearly 80%.