Analysis of ENGAGE Registry Found Similarly Strong Outcomes with Device for Endovascular Treatment of Abdominal Aortic Aneurysms in Short and Standard Neck Lengths
MINNEAPOLIS –– April 9, 2013 –– Presented to endovascular specialists at the 35th Charing Cross International Symposium in London, a new analysis of clinical data on the Endurant AAA Stent Graft System from Medtronic, Inc. (NYSE: MDT) demonstrates the implanted medical device’s consistent and compelling performance in treating abdominal aortic aneurysms across a range of patient anatomies, from relatively straightforward to highly complex.
This subset analysis of the international ENGAGE registry for the Endurant AAA Stent Graft, the market-leading device in its product category worldwide, compared the influence of neck length on patient outcomes. Specifically, the 2-year data demonstrated similarly strong outcomes in patients with neck lengths of 10mm to 15mm (short) and greater than 15mm (standard). Historically, shorter neck lengths have been associated with limited eligibility for endovascular repair and higher rates of adverse events.
“The Endurant AAA Stent Graft System continues to demonstrate durable performance for endovascular repair of abdominal aortic aneurysms in a variety of clinical and anatomical scenarios,” said presenter Prof. Hence Verhagen, chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the Netherlands. “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.”
The analysis included 123 patients with neck lengths of 10–15mm, 226 patients with neck lengths of 15–20mm and 873 patients with neck lengths of greater than 20mm. 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%)
- 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, which cannot be safely occluded. Neck length 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 10mm 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 the CE (Conformité Européenne) mark in June 2008. With 5-year follow-up planned for all patients, it represents the most robust long-term study of any stent graft ever initiated.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.