Functional mitral valve regurgitation (FMR) is considered a disease of the left ventricle, NOT of the mitral valve. FMR occurs when the left ventricle of the heart is distorted or dilated (enlarged), displacing the papillary muscles that support the two valve leaflets and stretching the valve opening (annulus). The valve leaflets can no longer come together to close the annulus and blood flows back into the atrium. If left untreated, FMR overloads the heart and can lead to or accelerate heart failure, a debilitating condition that affects 5.8 million people in the U.S. at a cost of $39.2 billion in 2010.¹
Current Surgical Treatment
Rather than replacing the diseased valve, surgeons favor repairing the valve with a procedure called Annuloplasty for over thirty years. This involves the implantation of a ring or band in the annulus to restore its normal shape. The surgical technique and annuloplasty ring design has not changed significantly over the last decade.
Annuloplasty is challenging to perform and very invasive (open-heart and on bypass), and because the cause of the FMR is not addressed (left ventricular distortion or dilation), regurgitation may reoccur in 40% or more of patients.2 Since the surgical risks are significant and there is a high rate of reoccurrence, only a small fraction of indicated patients undergo surgical procedures for FMR every year.3
1. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update. Dallas, Texas: American Heart Association; 2010.
2. The Journal of Thoracic and Cardiovascular Surgery, 2004;128:916-924.
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3. Dymedex Consulting, Market Opportunity Assessment performed for Mardil Medical,
May 2011. Dymedex.com >