FDA Approves Indication for Medtronic Endurant II/IIs Stent Graft System to Treat Short-Neck Anatomies
October 9, 2017—Medtronic announced that it has received US Food and Drug Administration (FDA) approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 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.
According to Medtronic, the FDA approval is supported by a short-neck cohort of the ANCHOR registry. The global, multicenter, multi-arm, 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.
In ANCHOR, outcomes from a subanalysis of 70 patients with proximal AAA neck lengths < 10 mm down to 4 mm who were treated with Endurant and Heli-FX demonstrated a technical success rate of 88.6%, based on delivery and deployment of the stent graft and each EndoAnchor implant used. The investigator-assessed procedural success rate was 97.1%, with a rate of 1.9% proximal type Ia endoleaks at 1 year. Additionally, there was only one type Ia endoleak that resulted in a secondary procedure through 1 year.
At 1 year, there were no AAA expansions, no instances of main body migration, and no instances of AAA ruptures. There was minimal EndoAnchor implantation time added to the overall procedure (average, 17 minutes), reported the company.
In Medtronic's announcement, Dr. Jordan commented, “Due to the complex and hostile proximal aortic neck anatomy, this patient population remains a challenge to treat. With minimal time added to the procedure, EndoAnchor fixation has been proven to enhance outcomes and durability, establishing a new treatment approach that addresses this critical patient need.”