Cordis Incraft System Studied in INNOVATION

April 11, 2010—Cordis Corporation (Bridgewater, NJ) announced that the first patients have been enrolled in the INNOVATION trial, which will assess the safety of the company's new Incraft stent graft system to treat abdominal aortic aneurysms (AAAs).

The INNOVATION trial is a multicenter, open-label, prospective, nonrandomized study that will enroll up to 25 AAA patients in three sites in Germany. The trial investigators are Professor Jan Brunkwall, MD, of Universitätkliniken in Cologne; Professor Dierk Scheinert, MD, of Park-Krankenhaus Hospital in Leipzig; and Professor Giovanni Torsello, MD, of St. Franziskus Hospital in Münster.

According to the company, the Incraft's delivery system features a low-profile that is made possible by using an integrated sheath of braided construction. The outer diameter of the integrated delivery system, which includes the device and sheath is 14-F, whereas currently available endovascular aneurysm repair (EVAR) devices have system profiles ranging from 18 to 24 F. Cordis noted that it has been developing Incraft with input from a multidisciplinary Physician Advisory Panel that includes Takao Ohki, MD, of Jikei University School of Medicine in Tokyo; Corey Teigen, MD, of MeritCare Vascular Center in Fargo, North Dakota; and Robert Bersin, MD, of Swedish Medical Center in Seattle, Washington. Dr. Ohki, who has one of the largest AAA practices in the world, stated, “I believe the Incraft stent graft system has the potential to impact how we treat AAA patients globally.”

Professor Scheinert performed the initial Incraft procedures. He commented, “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 ultralow- profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients.” Professor Torsello added, “The ability to customize the Incraft system during the procedure is a very helpful feature for clinicians.”