Minimally Invasive CARILLON Mitral Contour System Gets EU OK

European patients suffering from mitral regurg associated with dilated cardiomyopathy, usually from ischemic insults, may have a new minimally invasive procedure to fix their leaking mitral valves. Cardiac Dimensions out of Kirkland, Washington won EU’s CE Mark of approval for the company’s CARILLON™ Mitral Contour System™, a jugular vein access, percutaneous treatment for functional mitral regurgitation.
Details about the device:

The device is delivered percutaneously via jugular access under fluoroscopic guidance in a minimally invasive or non-surgical procedure called Percutaneous Mitral Annuloplasty. 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. Symptoms, such as shortness of breath and tiredness may also improve.
Cardiac Dimensions®, Inc. has obtained early clinical experience with a previous design of the CARILLON Implant. These studies were conducted in Europe, Paraguay, and Australia. To date, more than 50 people have been treated with the permanent implant. Preclinical and early clinical data have suggested both a reduction in mitral regurgitation in some patients, as well as, improvements along other key parameters including NYHA class, 6 Minute Walk distance, and Quality of Life.

Simple procedure < 1 hour

Results immediately observable

Tension is controlled / adjusted by physician – Intra-procedurally

Benign design, designed to be compatible with surrounding anatomy

Recapture Feature provides both “Safety Net” and “Ability to Optimize Result”

Does not preclude other HF therapies such as Bi-V pacing or surgery

Press release: Cardiac Dimensions(R) Inc. Receives CE Mark for CARILLON(TM) Mitral Contour System(TM)
Product page: CARILLON™ Mitral Contour System™