Cardiac Dimensions Launches IDE Trial of Carillon Mitral Repair System

The double-blind CARILLON trial will compare mechanical repair of functional mitral valve regurgitation with medical therapy alone in 400 patients at about 50 sites. The company is already running the REDUCE FMR randomized trial outside the US.

Cardiac Dimensions’ Carillon Mitral Contour Device
Cardiac Dimensions' Carillon Mitral Contour Device • Source: SOURCE: Cardiac Dimensions Pty. Ltd.

Cardiac Dimensions Inc.'s Carillon mitral contour system is moving closer to competing in the US mitral repair market with the start of the 400-patient CARILLON pivotal trial at about 50 sites, mostly in the US.

US FDA has approved an investigative device exemption for a trial that will randomize patients with symptomatic functional mitral valve...

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