Endurant Stent Graft System Receives FDA Expanded Approval

Medtronic received FDA approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm patients with neck lengths down to 4mm when used in combination with the Heli-FX EndoAnchor system.

The system was already approved in the U.S. for neck lengths >=10 mm and <=60° infra-renal angulation. With the new indication expansion, Endurant with Heli-FX EndoAnchor system has been approved by the FDA for use in patients with shorter neck lengths (less than 10mm down to 4mm).

The FDA approval was supported by a short neck cohort of the ANCHOR registry, a global multi-center, multi-arm, prospective, post-market registry evaluating the real-world applicability of the Heli-FX EndoAnchor system.