Analysis of Medtronic's ENGAGE Registry Presented at Charing Cross Symposium

April 9, 2013—Medtronic, Inc. (Minneapolis, MN) announced that a new analysis of clinical data on the company's Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated consistent performance in treating AAAs across a range of patient anatomies, from relatively straightforward to highly complex. Prof. Hence Verhagen, MD, presented the data at the 35th Charing Cross International Symposium in London, United Kingdom. Prof. Verhagen is Chief of Vascular Surgery at the Erasmus Medical Center in Rotterdam, the Netherlands.

According to Medtronic, this subset analysis of the international ENGAGE registry for the Endurant AAA stent graft compared the influence of neck length on patient outcomes. The 2-year data demonstrated similarly strong outcomes in patients with neck lengths of 10 to 15 mm (short) and > 15 mm (standard). Shorter neck lengths have historically been associated with limited eligibility for endovascular repair and higher rates of adverse events, noted the company.

“The Endurant AAA stent graft system continues to demonstrate durable performance for endovascular repair of AAAs in a variety of clinical and anatomical scenarios,” commented Prof. Verhagen in Medtronic's press release. “This specific subset analysis of the ENGAGE registry adds to the already large body of clinical evidence on this remarkably versatile device, which closes the outcomes gap between patients with short and standard neck lengths.”

As summarized in the company's announcement, the analysis included 123 patients with neck lengths of 10 to 15 mm, 226 patients with neck lengths of 15 to 20 mm, and 873 patients with neck lengths > 20 mm. The 2-year results demonstrated no statistically significant differences across these three groups on any of the following outcomes: type I endoleak (0.0%, 0.0%, 0.7%), stent graft migration (0.0%, 0.0%, 0.0%), aneurysm rupture (0.0%, 0.0%, 1.1%), conversion to open surgery (0.0%, 0.0%, 1.1%), and secondary procedures (4.2%, 6.3%, 6.6%). In this context, neck length is the span of healthy aortic tissue between the top of the aneurysm and the lowest renal artery that cannot be safely occluded, which determines how much of a landing zone is available for the proximal end of the stent graft.

The Endurant AAA stent graft is approved for use in patients with neck lengths of 10 mm or greater. The ENGAGE registry has enrolled more than 1,200 patients at more than 80 sites across six continents since the Endurant AAA stent graft system received CE Mark approval in June 2008. Five-year follow-up is planned for all patients, advised Medtronic.