First Patient Enrolled in HERCULES Trial of Medtronic’s Heli-Fx for Endosuture Aneurysm Repair

February 1, 2024—Medtronic with Rijnstate Ziekenhuis in Arnhem, the Netherlands, announced that the first patient has been enrolled in the HERCULES trial. Rijnstate is the sponsor of the study.

According to Medtronic, HERCULES is designed to compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) for patients who have an abdominal aortic aneurysm (AAA) with a wide infrarenal neck diameter.

Patients in HERCULES will be treated with either Medtronic’s Endurant II/IIs stent graft system (EVAR arm) or the Endurant II/IIs stent graft system in conjunction with Medtronic’s Heli-FX EndoAnchor system (ESAR arm). The study will enroll a total of 300 patients worldwide at approximately 20 hospitals in Europe and 20 hospitals in the United States.

Professor Michel M.P.J. Reijnen, MD, is Principal Investigator for the HERCULES trial.

“By securing the stent graft to the vessel wall in the neck with specially developed implants, called EndoAnchors, we try to prevent complications and associated re-operations,” commented Prof. Reijnen in a press release from Medtronic. “Next, we must investigate whether this is really the case. We will do that in the coming year.”

As noted by the company, patients treated for AAA require a healthy infrarenal neck as a landing zone in EVAR procedures. Recent publications have consistently shown that patients with wide infrarenal necks are at greater risk for proximal seal failure regardless of the endograft used to treat their AAA.

Additionally, data from the ANCHOR study showed promising results in treating hostile necks including wide neck anatomy. Prof. Reijnen presented the 3-year ANCHOR results in April 2022 at the Charing Cross International Symposium in London, United Kingdom. Higher level evidence will help to further guide treatment algorithms, noted the company.

More information (in English) is available on Rijnstate’s HERCULES trial website.

Rijnstate noted that patients will be followed for 5 years. The primary endpoint of the trial is a composite of outcomes measured via 1-year post-treatment contrast-enhanced CT-scans. The primary endpoint will be the absence of (1) type IA endoleak; (2) migration of the upper portion of the stent graft of ≥ 5 mm as compared to the 1-month post-treatment CT scan; and (3) aneurysm sac growth of ≥ 5 mm as compared to the 1-month post-treatment CT scan.