The approval was based on data that showed a technical success rate of 88.6% and a procedural success rate of 97.1%.
The US Food and Drug Administration (FDA) has announced approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients that have neck lengths down to 4 mm and ≤60º infra-renal angulation.
The stent graft, developed by Medtronic, is designed to be used with the Heli-FX EndoAncher system. It allows for a wider range of patients with hostile neck anatomies without renal stenting to be treated.
"Due to the complex and hostile proximal aortic neck anatomy, this patient population remains a challenge to treat," William Jordan, Jr., MD, professor of surgery and chief of the division of vascular surgery and endovascular therapy at Emory University School of Medicine, said in a statement. "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’s decision was made based on sub-analysis of data from the ANCHOR registry, co-led by Jordan, which evaluated 70 patients in the registry that had proximal AAA neck lengths <10 mm to 4 mm that were treated with Edurant and Heli-FX. The analysis showed a technical success rate of 88.6%, and a 97.1% procedural success rate.
Proximal-type Ia endoleaks occurred in 1.9% of patients through 1 year, and only 1 endoleak required a secondary procedure. There were no AAA expansions or occurrences of main body migration through that 1-year period, and an average of 17 minutes of implant time for there EndoAnchor was observed.
"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," Daveen Chopra, vice president and general manager of the Aortic business, part of the aortic & peripheral vascular division at Medtronic, said in the statement. "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."
Up to 30% to 40% of patients with AAA are defined as unsuitable for conventional endovascular aneurysm repair (EVAR), and according to recent Medtronic estimates, more than one-third of those patients have proximal neck anatomies of ≤10 mm.