Four-Year INNOVATION Results Support Cordis InCraft AAA Stent Graft System

November 19, 2015—Cordis Corporation, a Cardinal Health company, announced that 4-year data from its INNOVATION of the InCraft abdominal aortic aneurysms (AAA) stent graft system trial were presented by study investigator Prof. Giovanni Torsello, MD, at the 2015 VEITHsymposium in New York, New York. 

The trial is a multicenter, open-label, prospective study designed to assess the safety and performance of the device in the treatment of patients with AAA, with investigational sites in Germany and Italy. The trial results showed that after 4 years, the InCraft system performed well, with > 97% freedom from endoleaks and no stent graft migrations.

In the Cordis announcement, Prof. Torsello commented, “With the 4-year study results demonstrating continued performance with the InCraft system in Europe, Cordis’ device is clinically established in a class of next-generation AAA devices. In clinical practice, the InCraft system is easy to use and has one of the lowest profiles of any endograft on the market. I strongly believe that the InCraft system will continue to be a valuable option for physicians who remain eager for new technologies to enhance their ability to effectively treat patients with AAA.” Prof. Torsello is from the department of vascular surgery at St. Franziskus Hospital and University Clinic of Munster, Germany.

The InCraft system is intended for the endovascular treatment of patients with infrarenal AAA and features innovative technologies designed for durability, conformability, placement accuracy, and sealing without the need for polymers. The InCraft system is an ultra-low profile endovascular aneurysm repair system with a 14-F outer diameter, including the integrated sheath, which is equivalent to a 12 F catheter sheath introducer profile (16-F outer diameter for the 34-mm aortic bifurcate). Most endovascular aneurysm repair stent grafts have a system profile ranging from 16 to 22 F in size, noted the company.

Cordis advised that the InCraft system is approved for use and available for sale in Europe, Canada, Mexico, Colombia, and Brazil. In the United States and Japan, the InCraft system is for investigational device use only and was studied in the INSPIRATION trial, which completed enrollment in 2013.