Medtronic announced that its Endurant abdominal aortic aneurysm (AAA) stent graft system has shown long-term durability in a real-world setting in a 10-year post-market registry.
The Ireland-based healthcare technology company completed and presented the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) study data at the 2023 Charing Cross Symposium in London, UK.
According to Medtronic, the ENGAGE OUS registry is the first and only prospective, industry-sponsored global endovascular aneurysm repair (EVAR) registry to demonstrate a decade of durable outcomes through proven outcomes.
The Endurant stent graft system provides EVAR for the treatment of people with abdominal aortic aneurysm.
The ENGAGE registry assessed more than 1,200 patients. The 10-year data also included follow-ups from around 400 of these individuals.
As per the findings, patients demonstrated a 94.7% freedom from aneurysm-related mortality (ARM). It also showed 64.1% sac regression (or decreased AAA sac diameter) at 10 years.
Medtronic cardiac and vascular group aortic business VP and general manager Carolyn Sleeth said: “As Medtronic works to increase access to treatment for patients with Aortic disease, the 10-year results of the ENGAGE registry demonstrate a critical achievement in the commitment we have made to leading the advancement of EVAR.
“These data add to the current evidence showing that the Endurant stent graft system has a decade of proven long-term durable outcomes and allows physicians the opportunity to treat their patients with the most reliable device.”
The ENGAGE registry recruited patients from 49 sites in 21 countries. It started within a year after the medical technology company received the CE mark for the Endurant stent graft system.
Its objective was to collect data from a real-world patient population, including patients with difficult-to-treat anatomy and who are associated with lower eligibility for endovascular repair and have a higher rate of secondary treatments.
Medtronic said that a thorough monitoring protocol led to clinical follow-up compliance of 89.7% and imaging compliance of 68.3% at 10 years.
Recently, the company secured the US Food and Drug Administration (FDA) approval for its MiniMed 780G system with the Guardian 4 sensor and SmartGuard technology.
