Stent Graft System Gets FDA Committee Panel Backing

A US Food and Drug Administration (FDA) committee has provided a favorable recommendation towards the benefits of a stent graft device seeking market approval.

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee panel voted 11-4 to support the benefits of the INCRAFT AAA Stent Graft System from Cardinal Health. The INCRAFT system, an advanced endovascular aneurysm repair (EVAR) device designed to treat infrarenal abdominal aortic aneurysms (AAAs), is already available in 39 other countries.

With the panel’s backing, the device has moved a step closer to US markets and “thousands of high-risk patients,” Shaden Marzouk, MD, MBA, chief medical officer of Cardinal Health, said.

“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,” Marzouk said in a statement.

According to Cardinal Health, AAA affects about 1.5 million US patients — and another 200,000 new patients annually. Its effect on the aorta that could eventually result in rupturing could put patients at risk of a life-threatening hemorrhage. Currently, approximately 10,000 people die from aneurysms in the US annually.

Current treatment options for AAA include medical monitoring, open surgical repair, and EVAR. Though several EVAR devices are available in the US market, treatment for AAA patients with small femoral arteries, iliac arteries, or tortuous vessels are limited due to the risk of complications from EVAR devices.

The INCRAFT system differentiates in its flexible stent-graft system that is designed to prevent infrarenal AAA rupture, as proven in tested patient population.

The prospective, multi-center, single-arm INSPIRATION trial evaluated the safety and efficacy of the system in patients with AAA and aided in the favorable advisory committee vote, according to Cardinal Health. The trial results reported the INCRAFT system met primary endpoints, with a high rate of successful aneurysm treatment at 1 year and a low rate of major adverse events in patients at 30 days.

Recently reported trial data showed the device was associated in survival rates of nearly 80%, and no aneurysm ruptures reported in patients through 4 years of follow-up.