Approvals

Abbott has announced that the FDA has approved its Epic Max stented tissue valve to treat patients with aortic regurgitation or stenosis. The device is the newest in Abbott’s Epic surgical valve platform which the company has been developing for decades with positive results. Aortic regurgitation refers to when the aortic valve cannot close properly, while aortic stenosis refers to when it fails to open fully, both meaning the heart cannot pump blood effectively and blood flow to the body is reduced. This can lead to fatal heart failure, stroke and blood clots.

These diseased or damaged heart valves often cannot be repaired and so may be surgically replaced with either mechanical or bioprosthetic valves, such as Epic Max, which is recommended for patients who need valve replacement and aren’t suitable for blood-thinning medication.

Joseph E Bavaria MD, cardiovascular surgery, University of Pennsylvania, commented: “The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement. Abbott’s Epic

Max design optimises blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”

Michael Dale, senior vice president of Abbott’s structural heart business, added: “With Epic Max, we’re accomplishing two important things: first and foremost, we’re improving heart valve haemodynamics, which is the purpose of the procedure. Secondly, we’re preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection.”