Mitral Valve Contour System Reduces Regurgitation

Utilizing the heart's natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing FMR.

The device is delivered via percutaneous mitral annuloplasty, using jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted, and gently anchored into the coronary sinus and great cardiac vein to reshape the annulus around the mitral valve. The tension is then adjusted by the physician intraprocedurally, with a recapture feature that provides ability to optimize the result. The simple procedure takes under one hour, with results immediately observable. The enhanced Carillon Mitral Contour System is a product of Cardiac Dimensions (Kirkland, WA, USA), and has received the European Community (CE) marking.

“We believe Carrilon’s novel approach to addressing FMR holds significant promise for the millions of heart failure patients who suffer from this debilitating and progressive condition,” said Rick Stewart, president and CEO of Cardiac Dimensions. “This device is uniquely positioned to reverse the course of heart failure in this largely under-addressed patient population.”

FMR typically results from the dilation of the left ventricle; as it increases in size, the mitral valve also expands. This dimensional increase leads to mitral regurgitation, which significantly reduces the amount of blood flow out of the left ventricle to the body. FMR is associated with high rates of mortality, reduced functional capacity, poor quality of life, and an increase in hospitalizations. Current mainstream therapies to address FMR are limited, as most patients become refractory to medical therapy over time, and traditional surgical intervention is associated with high rates of operative morbidity and mortality.

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