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Ancora health4/19/2023 ![]() ![]() “The chronic and progressive nature of heart failure leaves many patients to face an increasingly challenging future as existing treatments, including medications and pacemaker devices, are not able to keep the disease at bay,” said Ulrich P. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices.Īs the only completely transcatheter procedure to treat the enlarged left ventricle, the AccuCinch System is a fundamentally different and innovative device-based therapy designed to improve the structure and function of the heart and help bring relief to HF patients who remain symptomatic despite current guideline-directed medical care. ![]() The FDA Breakthrough Devices Program expedites the development, assessment and review process for certain medical devices that provide for more effective treatment options for patients with life-threatening or irreversibly debilitating diseases or conditions. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System is designed to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. SANTA CLARA, Calif.-( BUSINESS WIRE)- Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S.
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