Medtronic touts 5-year data on CoreValve, 30-day results for Evolut R
Medtronic (NYSE:MDT) presented results from a pair of trials for its CoreValve line of transcatheter aortic valve replacements today at EuroPCR 2017 in Paris, touting 5-year data on the flagship CoreValve device and 30-day results for its next-generation Evolut R TAVR.
Five-year data from the 465-patient CoreValve Advance real-world study showed sustained hemodynamic improvement (9.7mm Hg mean gradient at discharge compared with 8.8 mm Hg at 5 years) and symptomatic improvement (81% classified as New York Heart Assn. class I or class II).
“As [TAVR] continues to be evaluated in lower-risk patients, the ability to demonstrate sustained valve durability over time is of increasing importance,” principal investigator Dr. Axel Linke, of Germany’s University of Leipzig Heart Center, said in prepared remarks. “At final, 5-year follow-up, we are very pleased with the excellent performance of the 1st-generation CoreValve device in the Advance study, which is 1 of the most rigorously designed global [TAVR] trials to date.”
Medtronic also cited 30-day results for its 1,038-patient Evolut R Forward study, which showed a 98.1% survival rate and a 1.8% disabling stroke rate. Mean gradient was reduced from 41.7mm Hg at baseline to 8.5mm Hg at discharge. The rate of mild or none/trace regurgitation was 98.1% and the rate of major vascular complications was 6.5%. Some 17.5% o patients required pacemaker implantation and there were no reports of valve thrombosis.
“The Forward results with a large patient cohort are encouraging, as these data support the clinical safety and effectiveness of the Evolut R system,” co-principal investigator Dr. Eberhard Grube said in a statement. “These initial 30-day outcomes help to further demonstrate the advantages of the recapturable and repositionable capabilities of the Evolut R system in routine clinical practice and we look Forward to conducting further follow-up that will provide insights on contemporary [TAVR] clinical practice.”
“With the recent expansion of [TAVR] into new patient populations, it’s critical that we collaborate with heart teams to not only demonstrate clinical improvements in real-world patient populations, but to show longer-term valve success,” heart valve therapies general manager Rhonda Robb said. “Low rates of stroke, excellent hemodynamics and high survival are consistent with the contemporary results we’ve seen from our self-expanding [TAVR] platform, which continue to improve as the technology advances.”
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