Medtronic (NYSE:MDT) said today that 4-year real world data from a subset of patients with challenging anatomy implanted with the Endurant AAA stent graft system showed durable outcomes. The data was presented at the VEITHsymposium in New York City.
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.
“Analysis of the patient cohort from the 4-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,” Dr. J.M.Verhagen of the Netherlands Erasmus University Medical Center said in prepared remarks.
The Fridely, Minn.-based medical giant reported low rates of aneurysm rupture and conversion to open surgery through the 4-year follow up, and no significant differences were found between cohorts in terms of secondary endovascular procedures.
“The global Engage registry demonstrates Medtronic’s unmatched commitment to clinical research on endovascular aneurysm repair. Through dedication to clinical data and innovation in technology, we hope to expand EVAR treatments to previously untreatable patient populations,” Aortic biz GM Daveen Chopra said in a press release.
In June, Medtronic said its Endurant abdominal aortic aneurysm stent is performing well, according to a 5-year follow-up study of the device. The announcement was made at the Society for Vascular Surgery’s annual meeting in Chicago.
The 5-year, 150-patient study data reported a 99.2% freedom from aneurysm related mortality and an 89% freedom from secondary endovascular interventions, the company said.
Data from the study indicated that 95.2% of patients’ aneurysm sacs remained stable or decreased in diameter by more than 5 mm and that no Type I or III endoleaks or migrations occurred in patients, Medtronic said.