Abbott Laboratories (ABT 0.49%) has scored a fresh victory across the Atlantic Ocean. The company announced Monday that it has been granted a CE Mark for its MitraClip G4, the latest version of its popular heart valve replacement device, which means it is approved for use in the countries of the European Union.
The G4 had already been approved for use in the U.S. by the Food and Drug Administration. It treats mitral regurgitation, a condition in which the mitral valve that sits between the left atrium and left ventricle of the heart fails to close properly. According to Abbott, this is a common heart condition -- among people 75 and older, one in 10 suffer from it.
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"This CE Mark, along with other recent approvals and advancements for our MitraClip device, underscores the need for MitraClip's innovative therapy -- which has become a preferred choice for the treatment of mitral regurgitation around the world," Abbott quoted Michael Dale, senior vice president of its structural heart business, as saying.
The MitraClip was developed in the late 1990s and early 2000s by a company called Evalve, which was bought by Abbott in 2009. The first version of the device was approved for use in Europe in 2008, and in the U.S. in 2013. According to Abbott, more than 30,000 patients have received MitraClips.
Despite the new regulatory green light, Abbott shares fell by almost 1.1% Tuesday, in contrast to the gains posted by the major equity indexes.
