Medtronic (NYSE:MDT) today released new data on its stent graft program at the Charing Cross Symposium in London, touting two-year results for its Endurant line and 30-day data from a pilot study of its Valiant Navion device.
The Fridley, Minn.-based medtech giant said preliminary two-year results from a study of the Endurant II/IIs devices, used with its Heli-FX EndoAnchor implants in 38 patients with short-neck aneurysms, showed a 94.3 rate of freedom from aneurysm-related mortality and a 95.5% rate of freedom from secondary endovascular procedure; one patient needed a proximal neck-related reintervention, Medtronic said.
There were no new or persistent type iA endoleaks or aneurysm sac enlargements and a 64.7% rate of sac regression of more than 5mm. There were no AAA ruptures or stent graft main body migrations, Medtronic said.
“By using an endosuture aneurysm repair approach with the Endurant stent graft and the Heli-FX EndoAnchor system, physicians are able to safely and effectively treat a wider range of patients with short aortic neck anatomies, independent of renal stenting,” said Dr. Frank Arko III, of Charlotte’s Sanger Heart & Vascular Institute, who presented the results in London. “At two years, the preliminary data also demonstrate that 100% of sacs are either shrinking or stable-an indicator of EVAR durability.”
Medtronic also released new 30-day data from all 100 patients in the Valiant Navion pivotal study of subjects with thoracic aortic aneurysm and penetrating atherosclerotic ulcer. The rate for both peri-operative mortality and secondary procedures was 2.0% and the rate of type Ia endoleaks was 1.1% and there were no instances of access or deployment failures, according to European principal investigator Dr. Fabio Verzini of Italy’s University of Turin, who presented the data at the Charing Cross forum.
“We are achieving success by innovating technology to treat more challenging anatomies and building confidence in our aortic pipeline through transparency in clinical data reporting,” aortic business GM John Farquhar said in prepared remarks. “Our dedication to addressing critical patient needs with solutions that are safe and improve outcomes is evident.”
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