Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System
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Tuesday, July 12, 2022
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Ancora Heart , Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch Ventricular Restoration System.
Key Points:
- Ancora Heart , Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch Ventricular Restoration System.
- The AccuCinch System is an investigational device designed to augment the existing care cardiologists provide their heart failure (HF) patients.
- The CORCINCH-HF pivotal trial is underway, designed to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).
- Ancora Heart is a medical device company dedicated to providing new treatment options for people with heart failure (HF).