The Incraft AAA system is under investigation through the company’s multi-center, prospective, non-randomized INNOVATION study in AAA patients, according to a press release.
About 24 million people have abdominal aortic aneurysms and 15,000 U.S. patients die every year due to rupture, according to a press release.
The Innovation study assessed the safety and efficacy of the the Incraft system at investigational sites in Germany and Italy.
Results of 1-year follow-up showed no incidence of aneurysm enlargement, endoleaks, device or procedure related major adverse events, stent graft migrations or stent fractures, investigators reported. All stent-grafts remained patent at 1-year follow-up, Cordis added.
“The Incraft system is designed to overcome the limitations of current AAA stent-grafts with its ultra-low profile, proximal and distal placement accuracy, ability to be customized during the procedure and broad anatomical coverage with a minimal number of product codes,” president Shlomi Nachman said in prepared remarks. “We believe the Incraft system has the potential to set a new standard in the field of endovascular AAA.”
The Incraft system is approved only for investigational use and it is not available for sale worldwide.