Medtronic's Endurant II/IIs System With Heli-FX EndoAnchor System Granted CE Mark Approval for Indication to Treat Short-Neck Anatomies
December 12, 2017—Medtronic announced that it has received European CE Mark approval for its Endurant II/IIs stent graft system to treat abdominal aortic aneurysm patients with neck lengths as small as 4 mm and ≤ 60° infrarenal angulation when used in combination with the Heli-FX EndoAnchor system. The expanded indication enables the treatment of a wider range of patients with short, hostile aortic neck anatomies independent of renal stenting. In October, the company announced US Food and Drug Administration approval for this expanded indication.
According to Medtronic, the CE Mark and US Food and Drug Administration approvals are supported by a short-neck cohort of the ANCHOR registry. The global, multicenter, multiarm, prospective, postmarket registry is evaluating the real-world applicability of the Heli-FX EndoAnchor system. ANCHOR is led by Co-Principal Investigators William Jordan Jr, MD, and Jean-Paul de Vries, MD.