FDA approves 2 new tissue valves for structural heart disease patients
Abbott has gained FDA approval for its Epic Plus and Epic Plus Supra stented tissue valves, two new treatment options for patients with aortic or mitral valve disease.
These next-generation solutions offer updates not seen in the company’s traditional Epic valves, including additional radiopaque markers and improved durability. They were also designed to be used without any need for blood-thinners.
“Whether it's developing new treatment options or improving upon our existing proven therapies, Abbott is constantly striving to deliver innovative solutions to address life-threatening heart conditions,” Michael Dale, senior vice president of Abbott's structural heart business, said in a prepared statement. “This FDA approval affirms our commitment to advancement of the Epic Platform and our mission to help people live better lives through better health.”
“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,” added Vinayak Bapat, MD, chief of cardiothoracic surgery at Abbott Northwestern Hospital. “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.”