Background
Trial Background
Heart Failure (HF)
Heart failure is a global pandemic, affecting around 26 million people worldwide, with increasing prevalence and considerable health costs that are expected to increase dramatically. Despite significant advances in therapies and prevention, mortality and morbidity rates are still high, with detrimental effects on patients’ quality of life.
Functional Mitral Insufficiency (FMR)
Severe FMR is present in 25-30% of patients with heart failure and is an independent predictor of mortality and hospitalizations in patients with both ischemic and nonischemic cardiomyopathy.
MitraClip
The MitraClip System was developed as a percutaneous technology to provide an option for treatment of patients with significant mitral regurgitation (MR). It is a small implanted clip attached to the mitral valve to help it close more completely and helps to restore normal blood flow through the heart
- The MitraClip System has been in clinical use since July 2003.
- The MitraClip System received CE-Mark approval in 2008 and is approved and commercially available in over 35 countries.
MitraClip
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