Abbott Laboratories said Friday that it has received U.S. regulatory approval for its MitraClip system to repair leaky heart valves in patients too frail to undergo surgery.
The Food and Drug Administration approved the catheter-based device for patients with significant mitral valve regurgitation who are not healthy enough to undergo surgery to repair or replace the valve.
Roughly 4 million Americans have mitral regurgitation, according to Abbott. It can cause blood to flow backward into the heart’s left atrium leading to irregular heartbeat, heart failure, a stroke or heart attack.
The MitraClip system is inserted through a catheter placed in the patient’s leg. It clips together leaflets of the heart’s mitral valve, which is between the left upper and lower chambers, and allows the heart to pump blood more efficiently.
Currently mitral regurgitation is treated with blood-thinning drugs for mild regurgitation or surgery for more severe cases.
North Chicago-based Abbott said it would launch the device in the U.S. immediately. It is already available in Europe and Abbott said it has implanted the device in more than 11,000 patients in 30 countries.