Medtronic touts Endurant stent graft data, lowered mortality

Medtronic (NYSE:MDT) today released data from the Engage global registry study of its Endurant abdominal aortic aneurysm stent graft, touting lowered mortality and rupture rates compared to the earlier Evar 1 trial.

Data from the studies was presented at the 2016 Charing Cross Symposium in London, Fridley, Minn.-based Medtronic said.

“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. 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 interventionalists 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,” Engage investigator Dr. Dittmar Böckler of Germany’s University of Heidelberg said in a press release.

The trial, which Medtronic said is the “most robust” post-market registry initiated in studying endovascular aortic repair, enrolled more than 1,200 patients at 79 sites and has follow-ups planned up to 10 years for patients enrolled.

Data from the trial reported a 1.6% rate of aneurysm-related mortality in the Engage registry through 4 years, down over 50% from the 3.5% rate reported in the Evar 1 trial and lower than the 6.3% reported for open surgeries, Medtronic said.

“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,” Evar 1 trial author Dr. Roger Greenhalgh said in prepared remarks.

The company also reported lower rupture rates in the Engage registry as compared with the Evar 1 trial, and a decreased rate of secondary intervention.

“Medtronic’s commitment to improving patient outcomes through clinical rigor is unsurpassed. As the leader in Evar, we continue to build upon our success and learnings from Engage to treat more complex aortic disease,” aortic biz GM Daveen Chopra said in a prepared

Last November, Medtronic touted 4-year real world data from a subset of patients with challenging anatomy implanted with the Endurant AAA stent graft system, saying it showed durable outcomes.

At 4-years, no differences in IA endoleak rate or AAA diameter increases were found between subsets of patients with short necks and standard necks, the company said, and freedom from aneurysm-related mortality was 99.2% for the short neck cohort and 98.3% for standard length neck patients.

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