Cordis announced on 10 September the launch of its Incraft AAA Stent Graft System, an ultra-low profile device for use during endovascular aneurysm repair (EVAR) for patients suffering from infrarenal abdominal aortic aneurysms. The Incraft System is cleared for use and is now available in Europe and Canada. According to Cordis, the device is an advancement in the EVAR field and provides a new option for patients and physicians seeking a less invasive treatment approach for abdominal aortic aneurysms.
The Incraft System, which features an ultra-low profile endovascular stent graft system with innovative technology designed for durability, conformability and sealing without the need for polymers, is intended to reinforce the lower part of the aorta to prevent an aneurysm from rupturing. The device is the lowest profile EVAR system now available in Europe and Canada with a 14F outer diameter, including the integrated sheath, which is equivalent to a12F catheter sheath introducer profile. Most EVAR stent grafts have a system profile ranging from 16–22F in size.
This ultra-low profile device is designed for proximal and distal placement accuracy and allows for customisation during the procedure to accommodate a wide range of anatomical sizes. This broad anatomical coverage is offered with a minimal number of product codes for easier pre-procedural planning.
“The Incraft System is an attractive new EVAR device option because its ultra-low profile design and customisation allows physicians to consider this less invasive procedure for many patients, especially those with smaller vasculature who might otherwise be ineligible for EVAR,” said Giovanni Torsello, of the St Franziskus Hospital Münster, Münster, Germany. “The recently published two-year data on the Incraft System from the INNOVATION trial in Europe demonstrated excellent performance adding to the scientific data supporting the device.”
The INNOVATION trial is a multicentre, open-label, prospective, non-randomised study designed to assess the safety and performance of the device in the treatment of patients with abdominal aortic aneurysm with investigational sites in Germany and Italy. At two years, results from the study demonstrated the device performed well in patients and showed no incidences of aneurysm enlargement, endoleaks (types I or III), 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. The two-year study results were presented at the 2014 Charing Cross Symposium and subsequently published in the July 2014 online issue of the Journal of Vascular Surgery.
The Incraft System is currently approved for investigational device use only in the USA and Japan and is being studied in a global pivotal clinical study in the US and Japan called the INSPIRATION trial, which completed enrolment in 2013.