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Self-expanding TAVR system approved for use in intermediate-risk patients
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Medtronic announced its self-expanding transcatheter aortic valve replacement platform has received an expanded FDA indication to include patients with symptomatic severe aortic stenosis who are at intermediate risk for open-heart surgery.
According to a press release from the company, the design of the platform (CoreValve Evolut) makes it appropriate for treatment of intermediate-risk patients often more active than high- to extreme-risk patients, who were previously indicated for the procedure.
The results of the SURTAVI trial, presented at the American College of Cardiology Scientific Session and published in The New England Journal of Medicine in March, showed that the self-expanding TAVR platform met its primary endpoint of noninferiority in all-cause mortality and disabling stroke compared with surgery in more than 1,600 intermediate-risk patients.
According to the release, at 2 years, patients treated with the TAVR platform also had better mean aortic valve gradients vs. patients who underwent surgery, while surgery was associated with less aortic regurgitation, major vascular complications and required permanent pacemaker implantation.
"As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well-suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays," Michael J. Reardon, MD, professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, said in a press release. "It's important to consider that in the first 30 days, patients treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study."
Disclosure: Reardon reports receiving fees from Medtronic for providing educational services.