FDA approves next generation of Abbott’s MitraClip heart valve device

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Abbott’s third-generation MitraClip transcatheter heart valve repair device got an FDA nod. (Abbott)

The FDA approved Abbott’s third-generation MitraClip transcatheter heart valve repair device that boasts advanced steering, navigation and positioning for placement by cardiologists.

The device, which was first approved by the U.S. regulatory agency in 2013, has been used to treat more than 65,000 patients globally in the past decade, the company said. That latest version, which won a CE Mark earlier this year, was designed for more precise placement during noninvasive surgery that allows for more predictable procedures, the company said.

The MitraClip is used to treat patients with significant degenerative mitral regurgitation and is delivered by a catheter inserted through the femoral vein in the leg. It then clips together parts of the mitral valve in a procedure that is less invasive than regular surgery.

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“Physicians rely on MitraClip as an alternative to surgery for patients who aren’t surgical candidates and may need treatment to relieve their symptoms or to survive,” Francesco Maisano, M.D., of the UniversitätsSpital Zürich, and an early user of the device, said in a statement. “The enhanced MitraClip design allows for even more precise navigation, accuracy and stability during valve repairs, which may be important when treating people with more complex or advanced valve disease.”

Additionally, the company announced it has begun enrollment in the MitraClip EXPAND clinical study that will evaluate the safety and performance of the new MitraClip system in a contemporary real-world setting. About 1,000 patients in 50 sites located in the U.S. and Europe are expected to be part of the study.