New data shows Heli-FX EndoAnchor System enhances outcomes and durability in complex aortic disease.- Medtronic.

Medtronic plc announced data demonstrating that the company's Heli-FX EndoAnchor system enhances outcomes and durability in patients with complex aortic abdominal aneurysm (AAA) anatomy, particularly those who have hostile aortic neck anatomy. The new data were presented in a series of three different presentations during the 43rd Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium) in New York. The findings are based on new sub-analyses from Medtronic's ANCHOR registry - a global, multi-center, multi-arm, prospective, post-market registry evaluating the real-world applicability of the Heli-FX EndoAnchor System in up to 2,000 patients.

1. ANCHOR Propensity Analysis - Data presented for the first time by Bart Muhs, M.D., Ph.D., a vascular surgeon at The Vascular Experts in Middletown, Conn., demonstrated outcomes in 99 patients who received EndoAnchor implants with the Heli-FX EndoAnchor system along with an approved stent graft during an endovascular aneurysm repair (EVAR) compared with 99 patients who did not receive EndoAnchor implants during EVAR. Patients in both arms of the ANCHOR propensity analysis (a statistical analysis of observational data) were matched using 19 anatomical and physiological baseline variables. After a mean follow up of over one year, patients in the ANCHOR test group experienced: 1.A statistically significant difference in sac regression: A cumulative sac regression was 28.6 percent in EndoAnchor implant group, and 20.3 percent in the non-EndoAnchor implant group (p=.017). 2.While not statistically significant, the results also showed: Less proximal neck dilation: freedom from neck dilation was 98.4 percent in the EndoAnchor test group versus 94.9 percent in the control group. Encouraging low rates of Type Ia endoleaks (an endoleak characterized by a poor seal): freedom from Type 1a endoleak in the EndoAnchor test group was 97.0 percent versus 94.1 percent in the control group.

2.ANCHOR Registry -Additional follow up data up from the ANCHOR registry were presented by William Jordan, M.D., professor of surgery and chief, division of vascular surgery and endovascular therapy at Emory University School of Medicine. The data, based on follow up of 604 patients, showed the Heli-FX EndoAnchor system provides additional security when used with approved endovascular stent grafts in patients with hostile AAAs.