Abbott has received the US Food and Drug Administration (FDA) approval for its Epic Plus and Epic Plus Supra Stented Tissue Valves to aid aortic or mitral valve disease treatment.
The Epic Plus Stented Tissue Valves are the latest addition to the company’s portfolio of surgical tissue and mechanical heart valve products.
When the damaged heart valves reach a point where they cannot be repaired, they may be replaced with either mechanical or bioprosthetic valves in open-heart surgery, said the company.
Epic Plus is a bioprosthetic valve indicated for patients requiring the replacement of a malfunctioning aortic or mitral heart valve.
The valve does not require blood-thinner medication, making it recommended option for people aged more than 70 years of age, who cannot take blood thinners.
With the FDA approval, the new-generation Epic Plus tissue valves are expected to widen the treatment options for patients undergoing valve replacement surgery.
Abbott Northwestern Hospital cardiothoracic surgery chief Vinayak Bapat said: “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.
“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.”
Epic Plus valve has been upgraded to include an increased number of radiopaque markers to enable doctors to easily navigate if transcatheter procedures are required in the future.
In line with the Epic surgical valve platform, the new valves are designed to deliver long-term performance and durability, and leverages its anticalcification technology, said Abbott.
The Epic Plus Mitral holder facilitates accurate insertion of the valve by providing physicians with a better view of the device during implantation.
It can be implanted in the aortic or mitral valve position and in patients with more complicated anatomies, said the company.
Abbott structural heart business senior vice president Michael Dale said: “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.
“This FDA approval affirms our commitment to advancement of the Epic Platform and our mission to help people live better lives through better health.”
