Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system.
The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced endovascular aneurysm system for treating infrarenal abdominal aortic aneurysms, the Dublin, Ohio-based company said.
The Incraft AAA system differs from other EVAR systems as it is intended to treat a wider range of patients, as many EVAR devices are limited from use for patients with small femoral or iliac arteries or those with heavily calcified or tortuous vessels, Cardinal Health said.
Cardinal Health said the panel’s positive vote was supported by data from a pivotal trial of the Incraft system, which met primary safety and effectiveness endpoints and showed a low rate of major adverse events at 30 days and a high rate of successful aneurysm treatment at one year.
“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 U.S. 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,” chief medical officer Dr. Shaden Marzouk said in a prepared statement.
The Incraft system won CE Mark clearance in the European Union in 2014, and is currently commercially available in 39 countries, the company said.