Houston, TX (July 30, 2019) – Procyrion, Inc., a medical device company developing percutaneous circulatory support devices for the treatment of heart failure, announced today that it has secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Aortix™ System. Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.
Breakthrough Designation is granted to certain medical devices and device-led combination products that provide a more effective treatment of life-threatening or irreversibly debilitating diseases. It enables manufacturers to provide patients and healthcare providers with timely access to medical devices by expediting their development, assessment, and review. Benefits of this designation…