Autus Valve receives Breakthrough Device Designation for congenital pulmonary valve disease

On August 25th, 2023 the US Food and Drug Administration (FDA) granted Autus Valve Technologies, Inc., Breakthrough Device designation for its novel pulmonary heart valve replacement device. The Autus Valve is a size-adjustable synthetic pulmonary heart valve that is specifically designed for pediatric patients.   

 

FDA Breakthrough Device designation is granted to medical devices that have the potential to provide more effective treatment of life-threatening conditions or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these novel medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval.