Patient enrolment completed in study of remote heart failure monitoring device

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FIRE1 today announced that it has completed patient enrolment in the US early feasibility study—FUTURE-HF2—of its FIRE1 system for remote heart failure monitoring.

The FIRE1 system is designed to directly measure a patient’s volume status by measuring the inferior vena cava (IVC) to better manage heart failure.

The FIRE1 study encompassed 15 patients treated at five centres across the USA, including Austin Heart Central at the Heart Hospital of Austin, NewYork-Presbyterian/Columbia University Irving Medical Center, Duke University Medical Center, Rochester General Hospital, and The Ohio State University Wexner Medical Center.

“Fluid build-up is challenging to accurately measure today and results in unnecessary hospital admissions due to fluid overload that was not caught early enough to be managed in the home,” said Nir Uriel, director of advanced heart failure and cardiac transplantation at NewYork-Presbyterian (New York, USA), and principal investigator of the study. “We are encouraged by our experience using the FIRE1 system and excited about the prospect of heart failure management becoming easier and more effective for both patients and for the clinical team.”

The FIRE1 system is a small, minimally invasive implantable sensor designed to accurately identify fluid build-up earlier, when it can be more easily managed by the patient and their physician without a hospital visit.

“It is gratifying to see the physician interest in our novel technology that earlier studies suggest should be a more sensitive measure than pressure in monitoring heart failure,” said FIRE1 CEO and president Conor Hanley. “We look forward to sharing the results of this study with the clinical community and conducting larger studies to validate the performance of the FIRE1 device. By enabling patients to better manage their fluid load, we hope to unload the burden on emergency rooms, helping hospitals focus on the most urgent patients who need immediate care rather than on acute management of heart failure.”


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