Next-generation mitral, aortic bioprosthetic surgical valves gain FDA approval
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Abbott announced the FDA has approved its next-generation stented bioprosthetic surgical valves for the treatment of aortic or mitral valve disease.
According to a company press release, the bioprosthetic valves (Epic Plus and Epic Plus Supra) do not require long-term use of blood-thinning medication, which lowers the risk for bleeding in patients at high risk for it and in those who cannot take blood thinners.
The next-generation valves include more radiopaque markers, making navigation easier if future transcatheter procedures are required. Additionally, the mitral holder for these valves has a lower profile that improves viewability of the device for accurate placement during implantation, according to the release.
“Doctors and patients have long depended on the Epic valve platform to help improve the quality of life for people in need of a surgical heart valve replacement," Vinayak Bapat, MD, chief of cardiothoracic surgery at Abbott Northwestern Hospital, said in the release. "With advancements made to Epic Plus, physicians can be assured of a reliable, longer-term solution for their patients needing a replacement heart valve that will also allow for future cardiac interventions if necessary due to the valve's accommodating design."
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