Abbott’s Epic Plus Tissue Valves Receive FDA Approval for Surgical Mitral and Aortic Valve Replacement

September 22, 2021—Abbott announced FDA approval of the company’s Epic Plus and Epic Plus Supra stented tissue valves to improve therapy options for patients with aortic or mitral valve disease. The devices feature new enhancements to Abbott’s Epic surgical valve that can improve implantation and allow compatibility for future transcatheter valve procedures.

According to the company, these next-generation devices build off Abbott’s Epic surgical valve platform and include innovations that make implantation of the valve and future cardiac interventions easier. Additionally, bioprosthetic valves like Epic Plus do not require long-term use of blood-thinner medication, making them the recommended option for patients who cannot take blood thinners or are over 70 years of age.

The approval of the new Epic Plus tissue valves provides a treatment option for patients undergoing valve replacement surgery without the need for long-term blood thinners, while providing a durable solution that allows for reinterventions as needed, stated the company.

Abbott further noted that Epic Plus includes more radiopaque markers that make it easier for doctors to navigate if future transcatheter procedures are needed.

In keeping with the Epic surgical valve platform, the new-generation valves feature the company’s anticalcification technology to provide long-term performance and durability. The Epic Plus mitral holder, which helps ensure precise insertion of the valve, has a lower profile so physicians have a better view of the device for accurate placement during implantation. The device can be implanted in the aortic or mitral valve position and in patients with more complicated anatomies.

“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,” commented Vinayak Bapat, MD, in the company’s press release. Dr. Bapat, who is Chief of Cardiothoracic Surgery at Abbott Northwestern Hospital in Minneapolis, Minnesota, continued, “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.”