Cordis Launches Incraft AAA Stent Graft System in Europe and Canada

September 10, 2014—Cordis Corporation announced the launch of its Incraft AAA stent graft system in Europe and Canada. The Incraft stent is an ultra-low profile device for use during endovascular aneurysm repair (EVAR) for patients with infrarenal abdominal aortic aneurysms (AAA). The device is currently not approved in the United States or Japan.

According to Cordis, the Incraft stent graft system is intended to reinforce the lower part of the aorta to prevent an aneurysm from rupturing. The device is designed for durability, conformability, and sealing, without the need for polymers. It features 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).

The ultra-low profile device is designed for proximal and distal placement accuracy and allows for customization during the procedure to accommodate a wide range of anatomical sizes. Additionally, this broad anatomical coverage is offered with a minimal number of product codes for easier preprocedural planning, noted Cordis.

In the company’s press release, Prof. Giovanni Torsello, MD, of the St. Franziskus Hospital Münster in Germany, commented, “The Incraft system is an attractive new EVAR device option because its ultra-low profile design and customization allows physicians to consider this less invasive procedure for many patients, especially those with smaller vasculature who might otherwise be ineligible for EVAR.”

Prof. Torsello added, “The recently published 2-year data on the Incraft system from the INNOVATION trial in Europe demonstrated excellent performance adding to the scientific data supporting the device.”

In July, the 2-year INNOVATION results were published online ahead of print in the Journal of Vascular Surgery. The results were presented in January at the LINC 2014 meeting in Leipzig, Germany, and in April at the 2014 Charing Cross International Symposium in London, United Kingdom.

The INNOVATION trial is a multicenter, open-label, prospective, nonrandomized study designed to assess the safety and performance of the Incraft device in the treatment of patients with AAA at investigational sites in Germany and Italy. At 2 years, results from the study demonstrated the device performed well in patients and showed no incidences of aneurysm enlargement, endoleaks (type I or III), device-related 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, advised the company.

In the United States and Japan, the Incraft system is currently approved for investigational device use only and is being studied in those countries in the global pivotal INSPIRATION clinical trial, which completed enrollment in 2013.