Two-Year INNOVATION Data on the Cordis InCraft AAA Stent Graft System Presented at LINC

January 28, 2014—Cordis Corporation (Bridgewater, NJ) announced the presentation of 2-year data from its INNOVATION trial at the LINC 2014 meeting in Leipzig, Germany. The company reported that the data support the InCraft system for the endovascular treatment of abdominal aortic aneurysms (AAAs) and that it performs well up to 2 years after the procedure.

According to Cordis, the INNOVATION trial is a multicenter, open-label, prospective study designed to assess the safety and performance of the InCraft endovascular stent graft system for the treatment of patients with AAA. The trial is being conducted at investigational sites in Germany and Italy. The device features an integrated delivery system with an ultra-low-profile equivalent to that of a regular 13-F catheter sheath introducer. This ultra-low-profile device is designed for accurate proximal and distal placement and can be customized during the procedure.

Study investigator Prof. Giovanni Torsello, MD, of the University Hospital Münster in Germany, presented the 2-year results of the INNOVATION study at LINC. At 2 years, there were no incidences of aneurysm enlargement, endoleaks (type I, III, or IV), device- or procedure-related major adverse events, stent graft migrations, or stent fractures. One patient in the study developed a late graft occlusion unrelated to the device that was caused by shrinkage of the aneurysm.

In the Cordis press release, Prof. Gioachino Coppi, MD, commented, “These positive results are encouraging and build on the favorable short- and midterm outcomes of the InCraft system observed in the recently published 1-year results of the INNOVATION trial. In light of these results and the unique low-profile configuration of the device, Cordis’ InCraft system has the potential to be a valuable alternative to current devices on the market. The system is designed to offer increased applicability in the broad spectrum of anatomical sizes encountered in patients undergoing endovascular aneurysm repair.”

Prof. Coppi et al published the 1-year INNOVATION results in the Journal of Cardiovascular Surgery (2014;55:51–59). Prof. Coppi is with the Department of Vascular Surgery at the University of Modena in Modena, Italy.

Cordis advised that the InCraft system is approved for investigational use only and is not for sale anywhere in the world. The device is currently being investigated in the INSPIRATION trial, a global, pivotal, clinical study in the United States and Japan that completed enrollment in August 2013. One-year follow-up data from the trial will support a premarket approval application to the US Food and Drug Administration and a Shonin application in Japan.