ENGAGE Global Registry and EVAR 1 Trial Data Presented for Medtronic's Endurant AAA Stent Graft

April 27, 2016—Medtronic plc announced the presentation of the ENGAGE global registry's postmarket experiences with the Endurant abdominal aortic aneurysm (AAA) stent graft system in endovascular aortic repair (EVAR); with a reference to the landmark EVAR 1 trial. The ENGAGE global registry is composed of more than 1,200 patients at 79 sites across six continents, with 10-year follow-up planned for all patients. The company noted that a decade ago EVAR 1 demonstrated better aneurysm-related survival for EVAR versus open surgery.

Dittmar Böckler, MD, presented the ENGAGE outcomes at the 2016 Charing Cross Symposium in London, United Kingdom. Dr. Böckler is from the Department of Vascular Surgery at the University of Heidelberg in Germany.

Through 4 years, aneurysm-related mortality was 1.6% in the ENGAGE registry. EVAR 1 demonstrated aneurysm-related mortality of 3.5% for EVAR and 6.3% for open surgery. The ENGAGE global registry also reported a lower rupture rate than in EVAR 1, as well as a decreased secondary intervention rate.

In the company’s press release, Prof. Roger Greenhalgh, MD, who is Chairman of the Charing Cross Symposium and author of the EVAR 1 trial commented, “The EVAR 1 trial is the world’s first randomized, controlled trial of EVAR compared with open repair using devices implanted between 1999 and 2005. It is therefore an appropriate benchmark against which newer-generation devices can be compared.”

Prof. Böckler stated, “In the comparison analysis of ENGAGE and EVAR 1, we can see just how far our medical advancements have come in improving patient outcomes with EVAR. The very well-structured EVAR 1 gave us the opportunity to understand the urgent need of improvement in EVAR, especially in mid- and long-term endograft behavior.”

He continued, “Thanks to large real-world registries, such as ENGAGE, we can do scrupulous analysis of different subgroups’ outcomes. The commitment from Medtronic to support a robust large scale registry is the type of clinical rigor that interventionists have come to rely on and will propel us into the future in treating more challenging anatomies with minimally invasive options and long-term durability.”

In a presentation at the 2015 VEITHsymposium, the ENGAGE registry data demonstrated that the Endurant AAA stent graft delivers durable, consistent, and proven outcomes at 4 years in real-world settings.

The Endurant system received European CE Mark approval in June 2008 and US Food and Drug Administration approval in December 2010. Outside the United States, the Endurant stent graft system is approved for use in patients with AAA neck lengths ≥ 10 mm and ≤ 60° infrarenal angulation and ≥ 15 mm with ≤ 75° infrarenal angulation. In the United States, the Endurant stent graft system is indicated for necks ≥ 10 mm and ≤ 60° infrarenal angulation.