Devices & Diagnostics

FDA device approval: Abbott gets a nod for less invasive mitral valve repair technology

Abbott Labs (ABT) announced it received FDA approval for MitraClip, a less-invasive mitral valve repair technology. The device allows physicians to repair the mitral valve using a catheter rather than open heart surgery for patients with mitral regurgitation. The company will launch the product in the U.S. immediately. While open heart mitral valve surgery is […]


Abbott Labs (ABT) announced it received FDA approval for MitraClip, a less-invasive mitral valve repair technology. The device allows physicians to repair the mitral valve using a catheter rather than open heart surgery for patients with mitral regurgitation. The company will launch the product in the U.S. immediately.

While open heart mitral valve surgery is the standard of care, for many patients, that’s not an option. For instance, Americans 75 and older, 10 percent of whom have mitral regurgitation. This device is inserted through the femoral vein with a catheter and then positioned. (Watch a simulation of placement in the video above.) In fact, according to a company statement, many of these patients are out of the hospital in two to three days.

“As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life,” Dr. Michael Mack*, director of Cardiovascular Research and Cardiovascular Medicine and director of Cardiovascular Surgery at Baylor Health Care System in Dallas, said in a press release. “With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life.”

Abbott will continue its clinical trials to test the MitraClip on progression of heart failure.

*Fun fact: Mack was one of the physicians who helped Randy Travis earlier this year.

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