Study Demonstrates Safety and Efficacy of New Customizable and Ultra-Low Profile Stent-Graft System for the Treatment of Abdominal Aortic Aneurysms
Bridgewater, New Jersey - November 17, 2012 - Cordis Corporation today announced the presentation of the INCRAFT™ AAA Stent-Graft System INNOVATION study one-year results at the 2012 Veith Symposium in New York City.
Investigator Professor Gioachino Coppi, MD, from the University of Modena and Reggio Emilia in Italy, presented the results of the INNOVATION study (A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED STUDY OF INCRAFT™ IN SUBJECTS WITH ABDOMINAL AORTIC ANEURYSMS) on behalf of the study investigators.
The INNOVATION study assesses the safety and efficacy of the INCRAFT™ System in treating patients with abdominal aortic aneurysms (AAA) at investigational sites in Germany and Italy. An estimated 24 million people worldwide have abdominal aortic aneurysms. Left untreated, most aneurysms will eventually rupture, with life-threatening consequences. In the U.S. alone, approximately 15,000 people die every year due to an AAA rupture.
"The INNOVATION trial results to date demonstrate favorable one year clinical outcome of the INCRAFT™ System with AAA. The innovative technologies of the INCRAFT™ System make it a valuable option to treat AAA patients in the future, including those that are currently not considered eligible for endovascular treatment," said the study's principal investigator, Professor Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology at Park-Krankenhaus Hospital in Leipzig.
The INNOVATION clinical study results at one-year follow-up demonstrate strong performance by the INCRAFT™ System. At one-year follow-up there were zero incidences of aneurysm enlargement, endoleaks (type I, III or IV), device or procedure related major adverse events, stent-graft migrations or stent fractures. All stent-grafts remained patent at one-year follow-up.
"We are excited about the clinical results for this innovative new endovascular AAA technology," said Shlomi Nachman, Worldwide President, Cordis Corporation. "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. We believe the INCRAFT™ System has the potential to set a new standard in the field of endovascular AAA."
Most traditional EVAR stent grafts available in the US and Japan have a system profile ranging from 18 to 24 French. The INCRAFT™ System provides an integrated delivery system with a profile equivalent to that of a regular 13 French catheter sheath introducer.
Cordis developed INCRAFT™, which is currently being investigated in a US-Japan pivotal clinical study, INSPIRATION, with input from a multidisciplinary Physician Advisory Panel that includes Dr. Corey Teigen, Department of Interventional Radiology, Sanford Medical Center, Fargo, ND, Dr. Takao Ohki, M.D., Chairman of the Department of Surgery at Jikei University School of Medicine in Tokyo, and Dr. Robert Bersin, M.D., Medical Director, Endovascular Services, Swedish Medical Center, Seattle, WA. The INSPIRATION pivotal study is being led by principal investigators Dr. Ohki and Dr. Michel S. Makaroun, M.D., Professor and Chair of the Division of Vascular Surgery at the University Of Pittsburgh School Of Medicine.
The INCRAFT™ System is approved for investigational device use only and it not for sale anywhere in the world.
Drs. Bersin, Makaroun, Ohki, Scheinert and Teigen are compensated for their consulting services and/or as members of the company's scientific advisory board.
About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson family of companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
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