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European mitral annuloplasty device trial concludes

A study into the use of a device for treatment of mitral regurgitation has concluded, the manufacturers have announced.

The AMADEUS™ (CARILLON™ Mitral Annuloplasty Device European Union Study), was conducted at six centres in Germany, Poland and the Netherlands, with the results to be presented to the European Society of Cardiology later this year.

The CARILLON Mitral Contour System, manufactured by US-based Cardiac Dimensions, combines a proprietary implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors.

The device is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted, and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation.

Commenting on the study, principal investigator Prof Joachim Schofer said:

“Throughout this study, both the investigators and the company learned a great deal about the percutaneous treatment of functional mitral regurgitation, which is a tremendous unmet clinical need.

“As the device evolved and the investigators’ technique was perfected, we found the CARILLON to be an effective and extremely simple tool for the management our patients.”

The device is currently under investigational use in Europe, South America and Australia only.

Cardiac Dimensions

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