Medtronic announced data demonstrating that the company's Heli-FX(TM) EndoAnchor(TM) 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.
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:
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).
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.
"This propensity matched data from the ANCHOR registry shows that the Heli-FX EndoAnchor system improves patient outcomes based on key measures of effectiveness," said Dr. Muhs. "
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.
Patients were evaluated in three groups who either received the Heli-FX EndoAnchor System prophylactically at the same time as an EVAR procedure (n= 314), as a therapeutic primary for a Type Ia endoleak occurring immediately after the EVAR (n=123), or as a therapeutic revision during a follow-up visit to treat a post-EVAR complication (n=167).
In all three groups, patients had very short necks, indicative of the hostile anatomy: median neck length was 11.5mm in the prophylactic group and 12.1mm in the therapeutic primary and 10.2mm in the therapeutic revision grou
Medtronic's Heli-FX and Heli-FX(TM) Thoracic EndoAnchor(TM) systems feature an endovascular deployed anchor designed to attach a variety of aortic endografts to the native vessel wall.
This off-the-shelf, customized solution minimizes the need for complicated procedures for the select subset of patients who would benefit from supplementary fixation.
This may include patients with challenging anatomies, risk factors for a secondary intervention, existing seal complications, as well as in situations where a physician may intraoperatively determine the need for additional security.
The Heli-FX and Heli-FX Thoracic EndoAnchor systems are cleared by the FDA for distribution in the United States and have been granted CE Mark for distribution in the European Union. Both products are also commercialized in other countries worldwide.
The Heli-FX and Heli-FX Thoracic EndoAnchor systems can be used with a wide variety of commercially available stent grafts, including Medtronic's Endurant® and Valiant® stent graft systems.