Cordis, a developer and manufacturer of interventional vascular technologies, has reported that the first patients have been enrolled in the Innovation trial to assess the safety of a new stent graft system Incraft in treating abdominal aortic aneurysm (AAA).
The Innovation trial (multicenter, open-label, prospective, non-randomized study of the Cordis AAA stent graft system in subjects with abdominal aortic aneurysm) is expected to enroll up to 25 patients in 3 sites throughout Germany.
The trial investigators are professor Jan Brunkwall, chairman of the department of vascular surgery at Universitatkliniken, Cologne, professor Dierk Scheinert, head of the department of medicine, Angiology and Cardiology at Park-Krankenhaus Hospital in Leipzig and professor Giovanni Torsello, chief of vascular surgery at St Franziskus Hospital in Muenster.
Reportedly, an estimated 27 million people worldwide have abdominal aortic aneurysms. Left untreated, all aneurysms will eventually rupture, and more than 80% of aneurysms that rupture result in death. In the US alone, approximately 15,000 people die every year due to an AAA rupture.
Campbell Rogers, chief scientific officer and head of global research and development of Cordis said: “The need for improved AAA treatments is significant. Current AAA stent-grafts limit the range of patients suitable for endovascular aneurysm repair (EVAR) and make delivery and placement accuracy challenging and complex, which can compromise short and long term safety of EVAR. We are very excited about the first-in-human use of our Incraft stent graft system, which we believe has the potential to set a new standard in the field of EVAR.”
Scheinert, professor, said: “We have been excluding a significant portion of our AAA patients, especially women, from EVAR because current stent grafts have large and bulky delivery systems, making device introduction impossible for small or diseased access vessels. The ultra-low profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients.”