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Functional Mitral Regurgitation

Mitral regurgitation ("MR") is caused by various mechanisms related to structural or functional abnormalities of the mitral apparatus, adjacent myocardium, or both. Unlike primary MR which is due to leaflet pathology (e.g., myxomatous degeneration or prolapse), functional mitral regurgitation ("FMR") results from dilation of the mitral annulus and left ventricle leading to chordal tethering and resulting inadequate leaflet coaptation. The clinical significance of FMR was not well understood prior to the development of percutaneous therapies designed to treat this functional abnormality of the mitral valve. With minimally invasive technologies generating groundbreaking clinical trial data, hemodynamic and functional data are now available to characterize the significance of treating FMR. Recognizing the specific anatomical and clinical requirements of treating this patient population, Cardiac Dimensions has designed an implantable device with the goal of reducing mitral regurgitation using a simple percutaneous procedure. The clinical trial results with this device are very promising.

CAUTION: The CARILLON® Mitral Contour System® is CE-Marked and approved for sale in the European Union and elsewhere in the world.
In the United States, the CARILLON Mitral Contour System is an investigational device and limited by Federal law to investigational use.

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