|Medtronic's Endurant AAA Stent Graft Delivers Durable, Consistent and Proven Outcomes at Four Years in Real-World Setting|
Four-Year Subset Analysis from Global ENGAGE Registry Demonstrates Positive Outcomes in Challenging Anatomies
DUBLIN and NEW YORK CITY- November 17, 2015 - Selected for nearly one of every two endovascular abdominal aortic aneurysm (AAA) repairs globally, the Endurant® AAA stent graft system from Medtronic plc (NYSE: MDT) continues to maintain durable and consistent outcomes at four years in real world settings, including challenging anatomies. Hence J.M. Verhagen, M.D., Ph.D., Professor and Chief of Vascular Surgery, Erasmus University Medical Center in Rotterdam, the Netherlands, presented on the market - leading stent graft on the opening day of the VEITHsymposium in New York City.
Patients with challenging anatomy have historically been associated with limited eligibility for endovascular repair and higher rates of adverse events. Dr. Verhagen's presentation focused on results across a range of patient anatomies.
"Analysis of the patient cohort from the four-year global ENGAGE registry included several anatomically challenging sub-groups: short, highly angulated, and calcium/thrombus burdened AAA necks. These mid-term outcomes offer clinical insight into the treatment of AAA neck anatomies relevant and applicable to current clinical practice and real world settings," said Prof. Verhagen.
At four-years, no significant differences were found between the short neck (>=10-<15mm) and standard neck (>=15mm) cohorts in terms of type Ia endoleak rate and AAA diameter increase. Low rates of aneurysm rupture and conversion to open surgery were demonstrated through four-year follow-up, and there was no significant difference between the cohorts in terms of secondary endovascular procedures. Freedom from aneurysm-related mortality (ARM) at four-years was 99.2 percent for the short neck cohort and 98.3 percent for the standard length necks.
The Endurant stent graft system is approved outside of the U.S. for use in patients with AAA neck lengths >=10 mm and <=60° infra-renal angulation and >=15mm with <=75° infra-renal angulation. In the U.S., the Endurant stent graft system is indicated for necks >=10 mm and <=60° infra-renal angulation.
The Endurant system received the CE (Conformité Européenne) mark in June 2008, and since that time the global ENGAGE registry has enrolled more than 1,200 patients at 79 sites across six continents. U.S. Food and Drug Administration (FDA) approval was received in December 2010. With ten-year follow-up planned for all patients, the ENGAGE registry represents the most robust post-market registry ever initiated.
Marc R.H.M. van Sambeek, M.D., Ph.D., Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands, will report on the four-year full cohort analysis from the global ENGAGE registry on Saturday, November 21.
"The global ENGAGE registry demonstrates Medtronic's unmatched commitment to clinical research on endovascular aneurysm repair (EVAR)," said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "Through dedication to clinical data and innovation in technology, we hope to expand EVAR treatments to previously untreatable patient populations."
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.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.