Medtronic Releases Three-Year Clinical Data Confirming Heli-FX EndoAnchor System as Safe, Effective, and Durable for Complex Aortic Aneurysms

Recently, VCBeat (WeChat Official Account: vcbeat) learned from foreign media reports that Medtronic, a global leader in medical technology, released three-year study data on its Heli-FX EndoAnchor System on November 16 (U.S. local time). The company stated that the system is safe, effective, and durable for patients with complex abdominal aortic aneurysms, particularly those with hostile aortic necks.

Medtronic offers two distinct fixation systems for EVAR (endovascular aneurysm repair) and TEVAR (thoracic endovascular aortic repair): the Heli-FX EndoAnchor System and the Heli-FX Thoracic EndoAnchor System. The Heli-FX EndoAnchor System is designed to secure and seal endovascular aortic grafts to the native artery. It is indicated for patients experiencing graft migration or endoleak, or those at risk for such complications, by sealing between the aortic graft and the native artery and enhancing radial fixation to restore and maintain adequate aneurysm exclusion. EndoAnchor implants can be deployed during initial endograft placement or as part of a repair procedure.

Image from Unsplash official website

The primary prevention and treatment amendment division of the Medtronic ANCHOR Registry is an evaluation system for the real-world applicability of the Heli-FX EndoAnchor, which conducted a three-year study on the Heli-FX EndoAnchor.

Medtronic stated that the study results included data from 800 patients with abdominal aortic aneurysm (AAA) who received combined treatment using the Heli-FX System in conjunction with endografts from Medtronic, Gore, Cook Medical, and Jotek. The study was divided into a larger prophylactic cohort and a smaller therapeutic cohort. Patients in the prophylactic group underwent direct EndoAnchor implantation, whereas patients in the therapeutic group continued with conventional endovascular repair, with EndoAnchor implantation performed only if the initial treatment failed.

After three years of research, data demonstrate that the Heli-FX EndoAnchor system provides transmural fixation for endografts, reduces aortic neck dilation, decreases the incidence of type Ia endoleaks, significantly increases the rate of positive sac regression, and alleviates patients’ concerns about future complications.

At the 45th Annual Vascular and Endovascular Issues Symposium in New York, Dr. William Jordan, Co-Principal Investigator at Emory University School of Medicine, evaluated the study findings.

“Malignant aortic aneurysms frequently present in clinical practice, posing challenges to physicians who treat patients using traditional endovascular approaches. With these data, we will continue to utilize Heli-FX in these challenging cases to achieve successful treatment outcomes in this patient population and to expand the applicability of EVAR to complex aortic aneurysms,” said Dr. William Jordan in a statement.

John Farquhar, Vice President and General Manager of Medtronic’s Aortic and Peripheral Vascular Business Unit, stated: “Our focus remains on improving the lives of patients with complex aortic disease through Heli-FX and expanding the applicability of endovascular repair. The data from this study further confirm that using EndoAnchors as a long-term solution can enhance patient care outcomes.”

Previously, the U.S. National Children’s Health System announced a partnership with Medtronic to develop a miniature pacemaker for infants.