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# Medtronic’s Endurant Gains Expanded Indication
- URL: https://www.fdaweb.com/medtronics-endurant-gains-expanded-indication/
- Published: 2025-10-13T12:00:00.000Z
- Updated: 2026-09-14T15:23:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160030

FDA has approved an expanded indication for Medtronic’s Endurant II/IIs Stent Graft System, allowing its use in abdominal aortic aneurysm (AAA) patients with short, challenging neck anatomies when used with the company’s Heli-FX EndoAnchor System. The approval enables treatment of patients with aortic neck lengths as short as 4 mm and up to 60° infra-renal angulation, significantly broadening the range of AAA patients eligible for endovascular aneurysm repair (EVAR), according to the company. These patients, often considered unsuitable for conventional EVAR due to short or “hostile” neck anatomy, previously had limited therapeutic options, it says.

Approval was based on results from the ANCHOR registry, a global, multicenter, post-market registry evaluating real-world outcomes of the Heli-FX EndoAnchor system. In a sub-analysis of 70 patients with proximal necks between 4–10 mm, the combination of Endurant and Heli-FX achieved a technical success rate of 88.6% and a procedural success rate of 97.1%, with only 1.9% experiencing a “Type Ia endoleak” at one year, the company says.

Medtronic says that no aneurysm expansions, graft migrations, or ruptures were reported through the first year of follow-up, and EndoAnchor implantation added an average of just 17 minutes to procedure time.