Irish medical technology firm Medtronic has secured CE mark approval for its Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) by using a ChEVAR procedure.
The procedure is a parallel graft chimney technique, which uses commercially available balloon expandable covered stents aggregated with a standard aortic stent graft.
The latest approval allows the firm to use Endurant II/IIs stent graft system for the treatment of patients with complex aneurysms with short aortic neck lengths ≥2 mm, expanded from the prior neck length indication ≥10 mm.
The approval was based on a review of clinical data from literature using the Endurant II/IIs stent graft system with the ChEVAR technique.
In the PROTAGORAS study, outcomes have been tracked with radiologic follow up over a mean of two years.
According to the company, the study results showed that standardized use of the Endurant II/IIs stent graft system with ChEVAR in 128 patients is associated with maximum technical success, statistically significant aneurysm sac regression, 95.7% primary patency of the chimney grafts and low incidence of chimney related reinterventions.
The Endurant II/IIs stent graft system is based on firm’s Endurant stent graft system that secured CE mark approval in June 2008.
Medtronic aortic and peripheral vascular division’s aortic business general manager and vice president Daveen Chopra said: “Medtronic is committed to partnering with our clinical community to provide solutions for challenging patients with complex aortic disease.
“The expanded indication for our Endurant II/IIs stent graft system is a great example of how we can deliver solutions to address unmet clinical needs and improve standard of care for patients who have aneurysms with short neck lengths.”