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preCARDIA procures Breakthrough Device Designation from FDA
ST. PAUL, Minn.—preCARDIA, Inc. has announced that the company’s novel 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).
“preCARDIA’s current technology, a proprietary balloon catheter and pump controller, is designed to address ADHF via intermittent superior vena cava (SVC) occlusion,” notes preCARDIA’s website. “By limiting venous return to the heart, preCARDIA treats fundamental ADHF clinical hemodynamic targets.”
The preCARDIA system is intended to rapidly and effectively reduce cardiac preload in the venous system, thereby improving overall cardio-renal function. The potential benefits for patients include improved response to medical management, reducing hospital readmissions and improved quality of life. The system is currently under investigation in the VENUS-HF Early Feasibility Study, which began in August 2019.
“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, president and CEO of preCARDIA.
The FDA’s Breakthrough Device program will provide preCARDIA with priority review and engagement with FDA experts from the premarket review phase through commercialization decisions. The Centers for Medicare and Medicaid Services (CMS) has also created an alternative new technology add-on payment pathway for technologies that have been granted a Breakthrough Device designation.
In the U.S., around 1.8 million patients are admitted to hospitals with ADHF each year — it is the leading cause of hospitalization in patients 65 and older. Mortality after ADHF hospitalization approaches 30% annually and readmission is common, despite the available pharmacotherapy and device-based heart failure treatments.
Most ADHF patients have significant volume overload and congestive symptoms, which are strong predictors of outcomes. Current therapeutic approaches are palliative; they alleviate some symptoms, but ADHF patients continue to experience poor morbidity and mortality outcomes. preCARDIA states that a need remains for new therapies focusing on providing effective and efficient cardio-renal volume unloading.
“The current ADHF treatment approaches are sub-optimal in many patients and have not improved over the past twenty years, thus new treatment options are critical,” added Navin Kapur, M.D., director of the Acute Circulatory Support Program at Tufts Medical Center, and chief medical advisor and chair of preCARDIA’s Scientific Advisory Board, in a press release about the VENUS-HF study. “We are excited to be pioneering a novel, minimally-invasive transcatheter treatment approach that has the potential to greatly improve the lives of patients suffering from ADHF.”