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|New Data Show Medtronic Heli-FX EndoAnchor System Enhances Outcomes and Durability in Complex Aortic Disease|
Data from ANCHOR Registry Demonstrate Applicability in Patients with Hostile Aortic Neck Anatomy
DUBLIN and NEW YORK - Nov. 17, 2016 - Medtronic plc (NYSE: MDT) today 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.
ANCHOR Propensity Analysis
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:
While not statistically significant, the results also showed:
"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. "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 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 group. Specific results evaluated by a core laboratory at one and two years for all three groups include:
"These data further support the added security and durability of the Heli-FX EndoAnchor System we are seeing in clinical practice," said Dr. Jordan. "With low rates of Type Ia endoleaks and re-intervention 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."
In a related presentation, Apostolos Tassiopoulos, M.D., department of surgery, division of vascular and endovascular surgery, Stony Brook University Medical Center, N.Y., presented data demonstrating effects of Heli-FX EndoAnchor system on neck dilation. This additional data from the ANCHOR registry characterized several variables predictive of perioperative neck dilation. The analysis showed that after one year, EndoAnchor implants appear to offer protection against neck dilation.
"We are excited to see the continued, positive data from the ANCHOR registry that demonstrate the strength and durability of our Heli-FX EndoAnchor system when used with EVAR in patients with hostile AAA anatomy," said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "Following our acquisition of Aptus Endosystems and its Heli-FX and Heli-FX Thoracic EndoAnchor systems last year, this technology further reflects our commitment in providing solutions for challenging patients with complex aortic disease based on real-world, rigorous clinical data."
Medtronic's Heli-FX EndoAnchorSystems
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. Medtronic also plans to pursue approval for use of the Heli-FX EndoAnchor system in patients with infrarenal proximal necks <10mm.
In collaboration with leading clinicians, researchers, and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular diseases and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.