FDA Approves Abbott’s Epic Plus for Aortic Valve Disease

FDA recently approved Abbott’s Epic Plus and Epic Plus Supra Stented Tissue Value to improve therapy options for individuals with mitral or aortic valve disease.

The next-generation devices built off Abbott’s Epic surgical valve platform, have shown strong impressive clinical outcomes and include innovations that make implantation of the valve and future cardiac interventions easier. 

“Abbott is constantly striving to deliver innovative solutions to address life-threatening heart conditions,” Michael Dale, senior vice president of Abbott’sAbbott's structural heart business, said in the announcement. “This FDA approval affirms our commitment to advancement of the Epic Platform and our mission to help people live better lives through better health.” 

Heart valve disease happens when one or more of the heart’s valves don’t open or close properly. When damaged heart valves can’t be repaired, they are surgically replaced with either mechanical or bioprosthetic valves in open-heart surgical procedures. 

Over 100,000 people in the US have conventional heart valve surgeries each year. The approval of Epic Plus tissue valves provides a vital treatment option for patients undergoing valve replacement surgery without the need for long-term blood thinners. 

Bioprosthetic valves like Epic Plus are the number one recommended option for individuals who can’t take blood thinners or are over 70 years of age. 

Abbott is the global leader in mechanical heart valves. The Epic Plus system is the latest addition to the company’s portfolio of surgical tissue and mechanical heart valves.

Epic Plus enhancements include radiopaque markers that make it easier for doctors to navigate if transcatheter procedures are needed. In addition, the new valves are designed to deliver long-term performance and durability. 

And the Epic Plus Mitral holder has a lower profile, so physicians have a better view of the device for accurate placement during implantation, an Abbott spokesperson 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,”" 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,” Bapat continued.