FIRE1, a connected medical device solutions company, announced the completion of patient enrollment in the U.S. 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 monitoring the inferior vena cava (IVC), the body's largest vein where most fluid is stored.
The FUTURE-HF2 study encompassed 15 patients across five centers in the U.S., 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.
Addressing Fluid Overload in Heart Failure
Fluid overload is a common clinical feature of heart failure, a condition affecting over six million people in the U.S. It is also the most frequent cause of hospitalization for individuals aged 65 and over. Current technologies often fail to directly measure fluid volume in the IVC, leading to delayed detection of fluid overload and subsequent hospital admissions.
"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 Dr. Nir Uriel, director of advanced heart failure and cardiac transplantation at NewYork-Presbyterian, and principal investigator of the study. "We are encouraged by our experience using the FIRE1TM 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, allowing for timely intervention by patients and physicians, potentially avoiding hospital visits. The goal is to enable patients to monitor and manage their fluid volume at home, similar to how continuous glucose monitoring has transformed diabetes care.
FIRE1's Vision for Heart Failure Management
"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. The company anticipates sharing the study results with the clinical community and plans to conduct larger studies to validate the device's performance. By empowering patients to better manage their fluid load, FIRE1 aims to reduce the burden on emergency rooms and hospitals.
