Cordis commences enrollment in safety trial of INCRAFT stent graft system for AAA

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technologies, announced today that the first patients have been enrolled in the INNOVATION trial, which will assess the safety of a new stent graft system, called INCRAFT™, to treat abdominal aortic aneurysm (AAA). 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 U.S. alone, approximately 15,000 people die every year due to an AAA rupture.

“The need for improved AAA treatments is significant”

"The need for improved AAA treatments is significant," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation. "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."

The INNOVATION trial (multicenter, open-label, prospective, non-randomized study of the Cordis AAA stent graft system in subjects with abdominal aortic aneurysm) will 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.

Professor Torsello commented, "I am pleased to be a part of the INNOVATION trial. The ability to customize the INCRAFT™ system during the procedure is a very helpful feature for clinicians." "We look forward to assessing the clinical benefits of this more individualized AAA therapy for patients in this study" added Professor Brunkwall.

The initial procedures using INCRAFT™ were performed by Professor Scheinert, who is serving as Principal Investigator of the INNOVATION trial. According to Professor Scheinert, "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."

Currently available EVAR devices have a system profile ranging from 18 to 24 French. INCRAFT's delivery system profile is 13 French.

Cordis has been developing INCRAFT™ with input from a multidisciplinary Physician Advisory Panel that includes Takao Ohki, M.D., Chairman of the Department of Surgery at Jikei University School of Medicine in Tokyo; Corey Teigen, M.D., Managing Physician Partner, MeritCare Vascular Center, Fargo, ND; Robert Bersin, M.D., Medical Director, Endovascular Services, Seattle Cardiology and Swedish Medical Center, WA.

"I believe the INCRAFT™ stent graft system has the potential to impact how we treat AAA patients globally." said Dr. Ohki, who has one of the largest AAA practices in the world.

The INNOVATION trial is sponsored by Cordis and both investigators and sites are under contract with Cordis to perform this research. The Physician Advisory Panel members are compensated for their time by Cordis.