Cordis Incraft™ AAA Stent Graft Promising 1 Year Clinicals

In short

Stent grafts have been in the news recently, most recently last week when Medtronic’s Valiant thoracic device got the FDA nod for extended indications, as we covered here.

Not yet at market, but progressing nicely through its clinicals, J&J subsidiary, Cordis Corporation has been trumpeting the presentation of the INCRAFT™ AAA Stent-Graft System INNOVATION study one-year results at the 2012 Veith Symposium in New York City. Data presented showed the investigational device to demonstrate no aneurysm enlargement, no endoleaks, no device-related adverse events and 100% 1 year patency.

Background

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.

Investigator Professor Gioachino Coppi, MD, from the University of Modena and Reggio Emilia in Italy, presented the results of the so-called INNOVATION study, a multicentre, open label, prospective, non-randomised study of INCRAFT™ in subjects with Abdominal Aortic Aneurysms (AAA). The INNOVATION study is assessing the safety and efficacy of the system in treating patients with AAA at sites in Germany and Italy.

One-year follow-up,  as reported during the Veith meeting, demonstrates 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.

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.
Investigator comments 

“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.

Company comments

“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.”

Regulatory status

The INCRAFT™ System is approved for investigational device use only and it not for sale anywhere in the world.

Source: Cordis Corporation, Business Wire