Three-Year Data From ANCHOR Registry Presented for Medtronic's Heli-FX EndoAnchor System
November 16, 2018—Medtronic announced the presentation of data on the Heli-FX EndoAnchor system by William Jordan Jr, MD, at the 45th annual VEITHsymposium held November 13–17 in New York, New York.
The company stated that the data from the Medtronic ANCHOR registry demonstrated the durability, safety, and efficacy of the Heli-FX device to treat patients with complex aortic abdominal aneurysm (AAA) anatomy, particularly those with hostile aortic neck anatomies.
According to the company, the conclusions are based on 3-year data from the primary prophylactic and therapeutic revision arms of the Medtronic ANCHOR registry, which is a global, multicenter, multi-arm, postmarket evaluation of the real-world applicability of the Heli-FX EndoAnchor system.
Medtronic stated that the clinical evidence demonstrates that the Heli-FX EndoAnchor system provides additional security when used with approved endovascular stent grafts in patients with hostile infrarenal AAAs. To date, more than 800 AAA patients treated with Heli-FX in combination with primarily Medtronic, Gore, Cook, and Jotec grafts have been enrolled in the ANCHOR Registry.
The majority of patients enrolled received EndoAnchor implants prophylactically. A smaller group received them after a previous failed endovascular repair (EVAR) treatment (therapeutic revision). The data presented by Dr. Jordan includes a subset of patients from these groups who were eligible for clinical and imaging follow-up at 3 years. Patients had short, hostile neck anatomies with median neck lengths of 11.2 mm in the prophylactic group and 10.2 mm in the therapeutic revision group.
Dr. Jordan reported the following results in the two arms:
- Low rates of type Ia endoleaks at 3 years: prophylactic = 1.7% (2/120); therapeutic revision = 2.4% (1/41)
- Positive sac stability and regression despite the hostile anatomy characteristics at 3 years: prophylactic = 96.5% (111/115); therapeutic revision = 80% (32/40)
- High rates of freedom from secondary procedures to treat type Ia endoleak based on Kaplan-Meier estimate through 3 years: prophylactic = 98.7%; therapeutic revision = 86.3%
- High rates of freedom from aneurysm-related mortality based on Kaplan-Meier estimate, which is notable given the short neck lengths, through 3 years: prophylactic = 98.3%; therapeutic revision = 91.1%
In Medtronic's announcement, Dr. Jordan, who serves as Coprincipal Investigator of the ANCHOR registry, commented, “Hostile aortic necks are frequently seen in clinical practice and have historically presented challenges for physicians treating patients through an endovascular approach. With these data, we are continuing to validate that by using Heli-FX in these challenging cases we have the ability to successfully treat this critical patient population and expand applicability of EVAR to those with complex aortic anatomies.” Dr. Jordan is Professor of Surgery and Chief, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine in Atlanta, Georgia.