ENGAGE Postmarket Registry’s 3-Year Data Support Medtronic’s Endurant AAA System

 

November 25, 2013—Medtronic, Inc. (Minneapolis, MN) announced that data from the global postmarket ENGAGE registry of the Endurant abdominal aortic aneurysm (AAA) stent graft system for endovascular aneurysm repair (EVAR) demonstrated long-term durability and consistent outcomes at 3 years in a real-world setting. ENGAGE investigator Dittmar Böckler, MD, presented the data at the VEITH symposium, held in New York on November 19–22, 2013.

The company noted that the ENGAGE registry has enrolled more than 1,200 patients at 79 sites across six continents since the Endurant system received European CE Mark approval in June 2008. US Food and Drug Administration (FDA) approval was received in December 2010. Five-year follow-up is planned for all patients in the registry.

Overall, durable results were sustained across a range of patient anatomies, including patients with more hostile aortic necks, which have historically been associated with limited eligibility for endovascular repair and higher rates of adverse events. The Endurant system is approved for use in patients with neck lengths ≥ 10 mm.

Medtronic advised that Dr. Böckler presented data for the 500 registry patients who have been evaluated out to 3 years. In the results (n-value represents the number of patients at risk for the event at 3 years), the graft-related complications were very low, with a 0% (n = 490) migration rate and a Type I/III endoleak rate of 1.5% (n = 333). Additionally, they show 90.7% (n = 388) freedom from secondary endovascular procedures and 98.4% (n = 417) freedom from aneurysm-related mortality. Positive results were also presented for the full 1,263-patient cohort evaluated at 2 years of follow-up. A rigorous monitoring protocol has resulted in follow-up compliance of more than 90% in the ENGAGE registry, noted Medtronic.

Additional analysis of the patient cohort revealed that 18% of patients enrolled had anatomical characteristics that did not fall within the current instructions for use, further suggesting that the findings are relevant and applicable to current clinical practice. In addition, 16% of patients had symptomatic abdominal aortic aneurysms and 10.5% were female, representing the single largest cohort of women in any EVAR trial (n = 133), according to the company.

Dr. Böckler, who is from the University Hospital of Heidelberg in Heidelberg, Germany, commented in Medtronic’s press release, “The size and scope of the ENGAGE registry distinguish Medtronic among stent graft makers as a committed partner in building the clinical evidence portfolio for EVAR worldwide. It is especially compelling to see that at 3 years, the Endurant system has maintained durable long-term outcomes in treating abdominal aortic aneurysms in a real-world cohort that represents the types of challenging anatomies physicians encounter in daily clinical practice.”

CE Mark approval for Medtronic’s second-generation device, Endurant II, was announced in January 2012. FDA approval and the United States launch of Endurant II were announced in June 2012.

 

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