Medtronic said that its Endurant Stent Graft System, an implantable medical device used in the minimally invasive treatment of abdominal aortic aneurysms, has delivered strong results through one year of patient follow-up in the company's US pivotal study.
The prospective study, approved by the US Food and Drug Administration (FDA) under an investigational device exemption (IDE), involved 150 patients at 26 US medical centers, met its primary endpoints.
In the study, the Medtronic Endurant System was associated with no post-operative aneurysm ruptures or aneurysm-related mortalities at one year, and there were no mortalities from any cause at 30 days.
The clinical study’s principal investigator Michel Makaroun said that based on this data, the Endurant Stent Graft, with its low-profile delivery system and accurate deployment, appears to be safe and effective in the short term.
"It will prove to be a great addition to the currently available devices in the management of abdominal aortic aneurysms for a wide range of patients," Makaroun said.
The study’s primary safety and effectiveness endpoints were major adverse events (MAE) at 30 days and a composite of technical and treatment success of the device at one year, respectively.
The study also monitored the occurrence and type of endoleaks, which can result in persistent blood flow into the aneurysm sac and through one year post-implant, there were no (zero) Type I or III endoleaks.