Medtronic (NYSE:MDT) 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 last Saturday.
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 Fridley, Minn.-based company said.
“The 5-year results from this study reinforce the long-term durability and consistency of the clinical outcomes that vascular specialists around the world have experienced with the Endurant AAA stent graft system. These results add to the growing body of evidence in support of the Endurant platform for endovascular AAA repair,” University of Pittsburgh Medical Center’s Dr. Michael Singh said in a press release.
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.
“The results of the current study demonstrate the durability of the Endurant system, with very good results up to 5 years that appear to be better than older generation endografts,” primary investigator Dr. Michel Makaroun of the University of Pittsburgh School of Medicine said in a prepared statement.
Delivery and deployment of the stent was successful in 99.3% of patients, with a mean procedure time of 101.5 minutes, Medtronic said.
“By delivering durable and consistent outcomes for patients with abdominal aortic aneurysms, the Endurant AAA stent graft system has the potential to deliver economic value to hospitals as well. These financial benefits come from reducing operational costs and readmissions,” MedStar Regional Vascular Program director Dr. Edward Woo said in prepared remarks.
In May, Medtronic said data from a 1,200-patient study of the Endurant AAA in patients with short and standard neck lengths showed a 99.4% success rate in standard-neck patients and 100% in short-neck patients.
In December, Medtronic cited positive long-term data from a U.S. IDE clinical trial that enrolled 150 patients, as well as positive four-year results from the first 500 patients in the Engage registry.