Fire1 Remote HF Monitoring System’s US Early Feasibility Study Completes Enrollment

February 28, 2024—Fire1, a medical device company headquartered in Dublin, Ireland, announced that it has completed patient enrollment in the FUTURE-HF2, the United States early feasibility study of its Fire1 system for remote heart failure monitoring.

According to the company, the Fire1 device is designed to directly measure a patient’s volume status by measuring the inferior vena cava to better manage heart failure. Fire1 is a small, minimally invasive implantable sensor intended to accurately identify fluid build-up earlier when it can be more easily managed by the patient and their physician without a hospital visit.

The FUTURE-HF2 study is composed of 15 patients treated at five centers in the United States: Austin Heart Central at the Heart Hospital of Austin in Austin, Texas; NewYork-Presbyterian/Columbia University Irving Medical Center in New York, New York; Duke University Medical Center in Durham, North Carolina; Rochester General Hospital in Rochester, New York; and The Ohio State University Wexner Medical Center in Columbus, Ohio.

Nir Uriel, MD, who is Director of Advanced Heart Failure and Cardiac Transplantation at NewYork-Presbyterian, serves as the principal investigator of the study. Dr. Uriel is also a professor of medicine in the Division of Cardiology at Columbia University Vagelos College of Physicians and Surgeons and an adjunct professor of medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine in New York.

“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,” commented Dr. Uriel in the company’s press release. “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.”