FDA Approves Cordis' InCraft AAA Stent Graft System
November 28, 2018—Cordis, a Cardinal Health company, announced FDA approval for the low-profile InCraft abdominal aortic aneurysm (AAA) stent graft system for endovascular aneurysm repair (EVAR) of infrarenal AAAs in complex access anatomies.
In June 2018, the InCraft system received a favorable recommendation by the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee after a review of clinical data from the pivotal INSPIRATION trial. Cordis advised that the InCraft system, which received CE Mark approval in 2014, is commercially available in many global geographies, including Canada and countries in the European Union, the Middle East, South America, and Asia Pacific.
Michel Makaroun, MD, Coprincipal Investigator of the INSPIRATION study, commented in the company's announcement, “We welcome the recent FDA approval of the InCraft stent graft system, which offers United States physicians a treatment option for patients with AAAs who otherwise might not be suitable for other EVAR devices. 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.” Dr. Makaroun is Professor and Chair of Vascular Surgery at the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.
Takao Ohki, MD, also a Coprincipal Investigator, added, "InCraft is an attractive new ultra-low-profile EVAR option that allows for bilateral in situ adjustment during the procedure, helping to minimize the need for additional components or extensions.” Dr. Ohki is Chairman and Professor of Surgery and Chief of Vascular Surgery at the Jikei University School of Medicine in Tokyo, Japan.