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Article: Cardiac Dimensions(R) Inc. Announces U.S. IDE Approval to Initiate the COMPETENT(TM) Pilot Study of the CARILLON(TM) Mitral Contour System(TM) for Treatment of Functional Mitral Regurgitation.
- Article from:
- Business Wire
- Article date:
- July 14, 2005
CopyrightCOPYRIGHT 2005 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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KIRKLAND, Wash. -- Study Approval Will Initiate the Evaluation of a "First-of-Its-Kind" Percutaneous Coronary Sinus-Based Treatment Approach
Cardiac Dimensions(R) Inc. announced today that the Food and Drug Administration (FDA) has recently granted the company Investigational Device Exemption (IDE) approval to initiate its COMPETENT(TM) Pilot study of the CARILLON(TM) Mitral Contour System(TM) for treatment of mitral insufficiency in patients suffering from Heart Failure. This insufficiency is a result of a progression of disease called Functional Mitral Regurgitation (FMR), which afflicts between 50-60% of all heart failure patients. The presence of FMR in a ...