FDA Approves Medtronic’s Stent Graft System for Short Neck Anatomies

Medtronic plc has announced that it has received U.S. 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 4mm and ≤60° infra-renal angulation when used in combination with the Heli-FX EndoAnchor system. The expanded indication enables the Endurant II/IIs stent graft to be used in conjunction with the Heli-FX EndoAnchor system to treat a wider range of patients with short, hostile aortic neck anatomies, independent of renal stenting.
 
Until now, some patients with short infra-renal necks (<10mm) were considered ineligible for endovascular aneurysm repair (EVAR), leaving them with limited treatment options. Up to 30 to 40 percent of patients with AAA disease are considered unsuitable candidates for conventional EVAR.¹ According to estimates from physicians across Europe and the United States, more than one-third of these patients have AAA proximal neck anatomies ≤10mm.²
 
“Due to the complex and hostile proximal aortic neck anatomy, this patient population remains a challenge to treat,” said William Jordan, Jr., M.D., professor of surgery and chief, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine and co-principal investigator of the ANCHOR registry. “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.”
 
The FDA approval is 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. Led by co-principal investigators Dr. Jordan and Jean-Paul de Vries, M.D., chief of Vascular Surgery at St. Antonious Hospital in Nieuwegein, the Netherlands, outcomes from a sub-analysis of 70 patients with proximal AAA neck lengths <10mm down to 4mm who were treated with Endurant and Heli-FX demonstrated a technical success rate of 88.6 percent, based on delivery and deployment of the stent graft and each EndoAnchor implant used, and a 97.1 percent procedural success rate (investigator-assessed), with a rate of 1.9 percent proximal type Ia endoleaks at one year. Additionally, there was only one type Ia endoleak that resulted in a secondary procedure through one year.
 
At one year there were no AAA expansions or instances of main body migration and through one year, no instances of AAA ruptures. There was minimal EndoAnchor implant time added to the overall procedure, with an average of 17 minutes.
 
“The acquisition of Aptus Endosystems in 2015 demonstrated our deep-rooted commitment to investing in solutions that treat complex aortic disease, and this new indication expansion for the Endurant II/IIs stent graft system is a significant milestone that underscores our promise to improve patient outcomes in partnership with the clinician community,” said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “With the use of the Heli-FX Endoanchor system, physicians can now provide durable seal and fixation with a proven stent graft technology to expand care to patients with hostile neck anatomies.”
 
References
¹ Skelly, Christopher L., and Ross Milner. Difficult Decisions in Vascular Surgery: an Evidence-Based Approach. Springer, 2017.
² Medtronic data on file.