preCARDIA, Inc., has announced that the company’s catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).

The FDA’s Breakthrough Device Program was established for medical technologies that have the potential to provide more effective treatment or diagnosis of life threatening diseases or conditions.  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 and Medicaid Services (CMS) has created an alternative new technology add-on payment pathway for technologies that have been granted a breakthrough device designation.

The preCARDIA system is intended to rapidly and effectively reduce congestion in the venous system, known as cardiac preload, thereby improving overall cardio-renal function.  The potential benefits for patients include improved response to medical management, reducing rehospitalizations, and improved quality of life.  The system is currently under investigation in the VENUS-HF 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,” said Lisa Wipperman Heine, preCARDIA’s President and CEO.

Source: preCARDIA, Inc. Receives FDA Breakthrough Device Designation for Novel, Catheter Based Heart Failure Treatment

Press Release by: preCARDIA, Inc.

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