PreCardia today said it received FDA breakthrough device designation for its catheter-based system that treats volume overload in patients with acutely decompensated heart failure.
The PreCardia system is designed to rapidly and effectively reduce congestion in the venous system to improve overall cardiorenal function. Patient benefits can include an improved response to medical management, reduced re-hospitalizations and improved quality of life.
The system currently under investigation in an early feasibility study.
“PreCARDIA’s technology has achieved an important milestone in securing the FDA’s Breakthrough Device Designation. We are thrilled to move forward in our collaboration with the FDA, prioritizing our submission reviews and supporting rapid access to this therapy for ADHF patients,” president and CEO Lisa Wipperman Heine said in a news release.
Through the breakthrough device designation, the company Will have priority review and engagement with FDA experts from the beginning of the pre-market review phase through commercialization decisions.