Medtronic touts 3-year Heli-FX EndoAnchor registry study data

Medtronic (NYSE:MDT) today released three-year data from the Anchor registry study of its Heli-FX EndoAnchor system, touting that it indicated the system is safe, efficient and durable in treating patients with complex aortic abdominal aneurysm anatomy, specifically those with hostile aortic neck anatomies.

Results from the trial were presented by co-principal investigator Dr. William Jordan of the Emory University School of Medicine at the 45th Annual Symposium of Vascular and Endovascular Issues in New York, the Fridley, Minn.-based company said.

“Hostile aortic necks are frequently seen in clinical practice and have historically presented challenges for physicians treating patients through an endovascular approach. 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,” Dr. Jordan said in a prepared statement.

The registry includes data from 800 AAA patients treated with the Heli-FX in combination with Medtronic, Gore, Cook Medical and Jotek grafts, the company said. The majority of patients received EndoAnchor implants prophylactically, while a smaller group in the registry received them following a previously failed endovascular repair treatment or therapeutic revision.

Data in the presentation came from patients eligible for clinical and imaging follow-ups at three years. Patients in the prophylactic group had short, hostile neck anatomies with median neck lengths of 11.2mm, while those in the therapeutic group had an average of 10.2mm neck length, Medtronic said.

At three years, results indicated a 1.7% rate of Type Ia endoleaks for patients in the prophylactic cohort, with a 2.4% rate for the therapeutic revision arm. Positive sac stability and regression despite hostile anatomy was observed at 96.5% in the prophylactic group at three years and 80% in the therapeutic revision group.

Patients in the prophylactic group experienced a 98.7% rate of freedom from secondary procedures to treat Type Ia endoleaks based on Kaplan-Meier estimates and a 98.3% rate of freedom from aneurysm related mortality based on the same estimates. Patients in the revision group had rates of 86.3% freedom from secondary procedures to treat Type Ia endoleaks and a 91.1% rate of freedom from aneurysm related mortality, Medtronic said.

“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. 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,” aortic biz GM & VP John Farquhar said in a press release.

Earlier this week, the Children’s National Health System announced that it was collaborating with Medtronic to develop a miniature pacemaker intended for use with infants.

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