The clinical trial INNOVATION, designed to evaluate the safety and effectiveness of the Incraft stent graft system from Cordis in patients with abdominal aortic aneurysms (AAA), has begun enrolling patients.
According to the Bridgewater, N.J.-based company, the INNOVATION (mult IceNter, opeN-label, pr ospectiVe, non-rAndomized sTudy of the Cord is AAA stent graft system in subjects with abdOminal aortic aNeurysm) trial, led by Dierk Scheinert of the Park-Krankenhaus Hospital in Leipzig, Germany, will enroll 25 patients at three sites in Germany.
Almost 27 million people globally are diagnosed with AAA and left untreated, and most AAAs will rupture and result in death, claiming the lives of 15,000 per year.
According to Cordis, current stent-graft systems make endovascular aneurysm repair (EVAR) in approved patients complex and can often compromise patient safety. Cordis said that the Incraft delivery system is size 13 F rather than current AAA devices which range from 18 to 24 F.