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Medtronic's newest expanding Evolut heart valve approved by US FDA

The U.S. Food and Drug Administration approved Medtronic PLC's Evolut Pro+ replacement heart valve, which comes in various sizes and expands to a patient's anatomy.

The Evolut line of heart valves is in a class called transcatheter arterial valve replacements, or TAVR, for the treatment of a narrowed valve that fails to open properly, a condition called aortic stenosis.

Medtronic said the new valve replacement can treat the broadest range of patients in terms of size. Its 23-millimeter, 26-millimeter and 29-millimeter valves can treat vessels as small as 5 millimeters, allowing easier placement of the devices inside a patient. There is also a 34-millimeter valve that can treat vessels as small as 6 millimeters wide.

The Evolut Pro+ valves have a wrapping that helps seal the connection with surrounding heart tissue to prevent leaks.

In study results released in March, Medtronic's line of Evolut replacement valves performed as well as surgery in treating low-risk patients with aortic stenosis.