November 17, 2015
Four-Year Subset Analysis From Global ENGAGE Registry Presented for Medtronic's Endurant Stent Graft
November 17, 2015—Medtronic plc announced that the Endurant stent graft system for endovascular abdominal aortic aneurysm (AAA) repair continues to maintain durable and consistent outcomes at 4 years in real-world settings, including challenging anatomies. Data on the Endurant stent graft system were presented at the VEITHsymposium in New York, New York, by Hence J.M. Verhagen, MD, who is Professor and Chief of Vascular Surgery at Erasmus University Medical Center in Rotterdam, the Netherlands.
At 4 years, no significant differences were found between the short neck (from ≥ 10 to < 15 mm) 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 4-year follow-up, and there was no significant difference between the cohorts in terms of secondary endovascular procedures. Freedom from aneurysm-related mortality at 4 years was 99.2% for the short-neck cohort and 98.3% for the standard-length necks.
In the company’s press release, Prof. Verhagen stated, “Analysis of the patient cohort from the 4-year global ENGAGE registry included several anatomically challenging subgroups: short, highly angulated, and calcium/thrombus burdened AAA necks. These midterm outcomes offer clinical insight into the treatment of AAA neck anatomies relevant and applicable to current clinical practice and real world settings.”
On November 21, Marc R.H.M. van Sambeek, MD, will report on the 4-year full cohort analysis from the global ENGAGE registry. Dr. van Sambeek is from the Department of Vascular Surgery at Catharina Hospital in Eindhoven, the Netherlands.
In the United States, the Endurant stent graft system is indicated for necks ≥ 10 mm and ≤ 60° infrarenal angulation. It received US Food and Drug Administration approval in December 2010. The ENGAGE postmarket registry is planned to provide 10-year follow-up results for all patients.
The Endurant stent graft system is approved outside of the United States for use in patients with AAA neck lengths ≥ 10 mm and ≤ 60° infrarenal angulation and ≥ 15 mm with ≤ 75° infrarenal angulation. The device received European CE Mark approval in June 2008. The global ENGAGE registry has enrolled more than 1,200 patients at 79 sites across six continents.