November 16, 2018
Medtronic plc today announced new data on the Heli-FX(TM) EndoAnchor(TM) system, which demonstrated durability, safety and efficacy in patients with complex aortic abdominal aneurysm (AAA) anatomy, particularly those with hostile aortic neck anatomies. The new data were unveiled in presentations at the 45th Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium) in New York. The findings are based on three-year data from the primary prophylactic and therapeutic revision arms of the Medtronic ANCHOR registry – a global, multi-center, multi-arm, post-market registry evaluating the real-world applicability of the Heli-FX EndoAnchor System.
“With Heli-FX, our focus continues to be on improving the lives of patients with complex aortic disease by broadening applicability of endovascular repair to patients who have traditionally been challenging to treat,” said John Farquhar, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “These data further validate the use of EndoAnchor fixation as a long-term solution that enhances outcomes and durability in patients with complex aortic anatomies.”
Three-year follow-up data up from the ANCHOR registry were presented by Dr. William Jordan Jr., M.D., professor of surgery and chief, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine and co-principal investigator of the ANCHOR registry. The clinical evidence demonstrates 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, while a smaller group received them following a previously failed endovascular repair (EVAR) treatment (therapeutic revision). The data presented today includes a subset of patients from these groups who were eligible for clinical and imaging follow up at three-years.
Patients had short, hostile neck anatomies with median neck lengths of 11.2mm in the prophylactic group, and 10.2mm in the therapeutic revision group. Specific results through three years include:
– Low rates of Type Ia endoleaks:
– At three years: prophylactic = 1.7 percent (2/120); therapeutic revision = 2.4 percent (1/41)
– Positive sac stability and regression despite the hostile anatomy characteristics:
– At three years: prophylactic = 96.5 percent (111/115); therapeutic revision = 80.0 percent (32/40)
– High rates of freedom from secondary procedures to treat Type Ia endoleak based on Kaplan-Meier estimate:
– Through three years: prophylactic = 98.7 percent; therapeutic revision = 86.3 percent
– High rates of freedom from aneurysm related mortality (ARM) based on Kaplan-Meier estimate, which is notable given the short neck lengths:
– Through three years: prophylactic = 98.3 percent; therapeutic revision = 91.1 percent
“Hostile aortic necks are frequently seen in clinical practice and have historically presented challenges for physicians treating patients through an endovascular approach,” said Dr. Jordan. “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.”
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.