Medtronic's Endurant System Continues to Show Positive Outcomes With New ENGAGE Registry Data

November 15, 2016–Medtronic announced that data from new subanalyses of the company’s ENGAGE Global Registry were presented at the 2016 VEITHsymposium being held November 15­–19, 2016 in New York, NY. The results were presented by Prof. Hence Verhagen, MD, PhD, Chief of Vascular Surgery at Erasmus University Medical Center in Rotterdam, the Netherlands.

According to the company, the new data reinforce the strength and durability of the Endurant II/IIs stent graft system used to treat patients with abdominal aortic aneurysms (AAA). In the first subanalysis, Prof. Verhagen reviewed the use of EVAR in patients with both standard and complex anatomies emphasizing type Ia endoleaks (an endoleak characterized by a poor seal at the aortic neck). Per the subanalysis, patients were free from type Ia endoleaks for up to 4 years, with rates of 97.8% (1 year), 97.3% (2 years), 96.7% (3 years), and 96% (4 years). Similar results were seen in subanalyses of both standard and complex patients at all time points.

"The impact of a type Ia endoleak is serious and includes an increased risk of rupture and the need for reintervention,” commented Prof. Verhagen in the company’s press release. “This new analysis provides further evidence of the benefits of EVAR in patients with both standard and complex anatomies, and it reflects the low endoleak rates that can be achieved with the Endurant stent graft system.”

A second subanalysis of the ENGAGE registry data, also presented by Prof. Verhagen, showed that Endurant achieves positive results in patients with various hostile neck anatomy, which include highly angulated, conical, and circumferential thrombus/calcium. At 4 years, these midterm outcomes, such as aneurysm related mortality, rupture, and conversion to open surgical repair, offer clinical insight into the treatment of AAA neck anatomies that is relevant and applicable to current clinical practice and real-world settings.

In addition, Prof. Dittmar Böckler, MD, Department of Vascular Surgery, University of Heidelberg, Germany and ENGAGE investigator, had previously reviewed data from the ENGAGE registry outcomes with regards to the flagship EVAR 1 study. These results, which were first presented at Charing Cross Symposium in April 2016, showed that Endurant was more effective than the previous generation of endografts evaluated in EVAR 1 trial, with a 54% relative risk reduction in aneurysm-related mortality rates, a 44% relative risk reduction of rupture, and a 35% relative risk reduction in secondary interventions. The findings support the use of Endurant in a wide range of patients.

The Endurant stent graft system received CE Mark approval in 2008 and US Food and Drug Administration approval in 2010. In the United States, the device is indicated for use in patients with AAA neck lengths ≥ 10 mm and ≤ 60° infrarenal angulation and ≥ 15 mm with ≤ 75° infrarenal angulation. Since 2008, ENGAGE has enrolled more that 1,200 patients across 79 sites on six continents and represents the most robust post-market registry ever initiated to study endovascular aortic repair.