Medtronic's Heli-FX EndoAnchor System Yields Positive Results for Patients With Hostile Aortic Neck Anatomy

November 17, 2016—Medtronic announced a series of new data on its Heli-FX EndoAnchor system that show enhanced outcomes and durability in patients with complex aortic abdominal aneurysm (AAA) anatomy, particularly those who have hostile aortic neck anatomy. The data are based on subanalyses of Medtronic's ANCHOR registry and were presented at three different presentations at the 43rd Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium).

The first set of data were presented by Bart Muhs, MD, PhD, Vascular Surgeon at the Vascular Experts, Middletown, Connecticut. Dr. Muhs reported outcomes for 99 patients who received EndoAnchor implants with the Heli-FX EndoAnchor system along with an approved stent graft during endovascular aneurysm repair (EVAR) compared with 99 patients who did not receive EndoAnchor implants during EVAR. After a mean follow-up of 1 year, there was a statistically significant difference in cumulative sac regression of 28.6% in EndoAnchor implant group compared with 20.3% in the non-EndoAnchor implant group (P = .017).

"This propensity-matched data from the ANCHOR registry shows that the Heli-FX EndoAnchor system improves patient outcomes based on key measures of effectiveness," commented Dr. Muhs in the company’s press release. "Our analysis reflects real-world clinical experience and provides the next level of clinical evidence supporting this EndoAnchor system in patients with complex, hostile abdominal aortic aneurysms."

In the second presentation, William Jordan, MD, Professor of Surgery and Chief of the Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine, noted that the Heli-FX EndoAnchor system provided additional security when used with approved endovascular stent grafts in patients with hostile AAAs.

The data were based on follow-up of 604 patients assessed across three groups. Patients either received the Heli-FX EndoAnchor system prophylactically at the same time as EVAR (n = 314), as a therapeutic primary for a type Ia endoleak that occurred immediately after EVAR (n = 123), or as a therapeutic revision during a follow-up visit to treat a post-EVAR complication (n = 167).

Two-year follow-up data across all three groups (prophylactic, therapeutic primary, and therapeutic revision) showed low rates of type Ia endoleaks (0.0% vs 2.9% vs 11.1%); positive sac regression despite the hostile anatomy characteristics (61.2% vs 51.4% vs 37.9%); high rates of freedom from secondary procedures (92.1% vs 92.9% vs 79.9%); and high rates of freedom from aneurysm-related mortality (ARM; 98.4% vs 98.4% vs 92.6%), which is notable given the short neck lengths (median neck length, 11.5 mm, 12.1 mm, and 10.2 mm, respectively).

"With low rates of type Ia endoleaks and reintervention rates, positive sac regression, and freedom from ARM rates, EndoAnchor implants allow for safe and effective treatment of more complex anatomies, both prophylactically and in conjunction with treatment of a post-EVAR complication, such as a migration or type Ia endoleak," commented Dr. Jordan.

In a related presentation, Apostolos Tassiopoulos, MD, with the Department of Surgery, Division of Vascular and Endovascular Surgery, Stony Brook University Medical Center, presented data showing the effects of Heli-FX EndoAnchor system on neck dilation. These additional data characterized several variables predictive of perioperative neck dilation, finding that EndoAnchor implants appeared to offer protection against neck dilation after 1 year.

The ANCHOR registry is a global, multicenter, multiarm, prospective, postmarket registry evaluating the real-world application of the Heli-FX EndoAnchor system in up to 2,000 patients. The Heli-FX EndoAnchor system is approved for use in the United States by the US Food and Drug Administration and has been granted CE Mark for distribution in Europe.