Cordis has announced that the US Food and Drug Administration (FDA) has approved its INCRAFT AAA Stent Graft System for use in complex access anatomies. The INCRAFT system is an ultra-low profile and flexible endovascular aneurysm repair (EVAR) system designed to treat infrarenal abdominal aortic aneurysms (AAA).
The system was given a favorable recommendation on 12 June by a Circulatory System Devices Panel of the Medical Devices Advisory Committee, following a review of clinical data from the pivotal INSPIRATION trial, a prospective, multicentre, single-arm study designed to evaluate the safety and effectiveness of the system in patients with AAA. The trial showed that INCRAFT met the primary safety and effectiveness endpoints, with a low rate of major adverse events at 30 days, high rates of successful aneurysm treatment and survival, and no aneurysm ruptures through four years of follow-up.
“We welcome the recent FDA approval of the INCRAFT stent graft system which offers US physicians a treatment option for patients with AAAs who otherwise might not be suitable for other EVAR devices,” said Michel Makaroun, professor and chair of vascular surgery at the University of Pittsburgh Medical Center, and co-principal investigator of the INSPIRATION study. “While EVAR systems have advanced rapidly over the years, there still remains a need for a low-profile EVAR device that is designed to be easy to deliver in complex access anatomies while facilitating precise placement.”
“INCRAFT is an attractive new ultra-low profile EVAR option that allows for bilateral in-situ adjustment during the procedure, helping to minimise the need for additional components or extensions,” said Takao Ohki, chairman and professor of Surgery and chief of Vascular Surgery at the Jikei University School of Medicine in Tokyo, Japan and co-principal investigator of the INSPIRATION study.
While several EVAR devices are currently available in the USA, 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.