The latest generation of Abbott’s market-leading MitraClip device for repairing leaky heart valves was approved with newly flexible steering, navigation and positioning capabilities, for more precise placement during the minimally invasive procedure.
The new features make the device easier to use in patients with complex or difficult anatomies, the medtech giant said. It also includes a second clip size with longer arms to expand its reach.
It's designed to halt the backward flow of blood that can occur following advanced heart failure or a damaged heart valve, known as mitral regurgitation. With each heartbeat, a small amount of blood leaks out of the left ventricle through the flaps of the valve and back into the connected atrium, as the heart works to pump blood to the aorta and the rest of the body.
Abbott’s MitraClip works to hold those valve flaps together in the middle, with the pinch creating two side openings in the valve for blood to flow through while forming a tighter seal—it’s a lower-impact procedure, compared to a full replacement of the mitral valve. As one of the most common heart valve diseases, mitral regurgitation affects one in 10 adults over the age of 75.
Following its approval by the FDA last July, Abbott released data from a study showing that the addition of its MitraClip device to standard drug therapies improved survival and reduced the rate of hospitalizations, reducing a composite score of the two risks by 43%.
The two-year study met its endpoints and helped form the basis of the device’s expanded FDA approval, granted this past March, in a secondary form of the condition known as functional mitral regurgitation—making the MitraClip the first transcatheter intervention in the wider indication, the company said.
As a result, Abbott estimates that two to three times as many patients may be eligible for MitraClip treatment for secondary disease, as a result of underlying heart failure, compared to those treated for the primary or degenerative form of mitral regurgitation.
In 2018, the MitraClip device also helped drive a 12.9% increase in Abbott’s U.S. sales within its structural heart segment compared to the year before, up to a total of $488 million. Now with the third generation of the device since it was first approved by the FDA in 2013, the MitraClip has been used in more than 80,000 patients worldwide, according to the company.
Currently, Abbott is developing a similar, clip-based intervention for the other main heart valve, the tricuspid valve of the right ventricle.