The FDA has approved of St. Jude Medical’s Epic Stented Tissue Valve with Linx AC technology.
Identical in design to its Biocor Valve, St. Jude said its Epic Valve also incorporates patented anti-calcification technology designed to protect against tissue mineralization, or hardening.
FDA approved the Epic Valve after a clinical study was conducted under a regulatory investigational device exemption. The study evaluated the valve's safety and efficacy as measured by hemodynamics, patient ability to perform everyday activities as measured by the New York Heart Association functional classification system and adverse effects, according to the company. The study included 762 patients at 19 U.S. sites and three Canadian sites.
The St. Paul, Minn.-based St. Jude said the Epic Valve will begin in early 2008.