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 MULT ICE NTER, OPE N LABEL, PR OSPECTI VE, NON-R ANDOMIZED S TUDY OF INCRAFT™ IN SUBJECTS WITH ABD OMINAL AORTIC A NEURYSMS) 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.”
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