June 23, 2020
PreCardia’s System to Treat Acute Decompensated Heart Failure Granted FDA Breakthrough Device Designation
June 23, 2020—PreCardia, Inc. announced that the company’s catheter-based system for treating volume overload in patients with acute decompensated heart failure (ADHF) has been designated for the FDA Breakthrough Devices program.
The program provides PreCardia with priority review and engagement with FDA experts from the beginning of the premarket review phase through commercialization decisions. In addition, the Centers for Medicare & Medicaid Services has created an alternative new technology add-on payment pathway for technologies that have been granted a breakthrough device designation.
According to the company, PreCardia’s balloon catheter and pump controller are designed to address ADHF through cardiorenal volume unloading via intermittent superior vena cava occlusion. The PreCardia system is intended to rapidly and effectively reduce congestion in the venous system (known as cardiac preload), thereby improving overall cardiorenal function. The potential benefits for patients include improved response to medical management, reduced rehospitalizations, and improved quality of life.
The PreCardia system is currently under investigation in the VENUS-HF early feasibility study. The device is limited by United States law to investigational use, advised the company.