Emerging vendor FIRE1 announced that it has completed patient enrollment in an initial feasibility study in the United States for a heart failure remote monitoring device that directly measures a patient’s fluid volume status within the inferior vena cava (IVC).

According to the company, the FIRE1 system is the first device designed to directly measure a patient’s volume status by measuring the largest veins in the body, where most of the body’s fluids are stored.

The FUTURE-HF2 feasibility study will involve five centers across the country: Austin Heart Central at Austin Heart Hospital, NewYork-Presbyterian/Columbia University Irving Medical Center, Duke University Medical Center, Rochester General Hospital, Ohio Fifteen patients treated at the state were included. Wexner University Medical Center.

“Currently, it is difficult to accurately measure fluid accumulation, leading to unnecessary hospital admissions due to fluid overload that is not detected early enough to be managed at home,” said the principal investigator. said Dr. Nir Uriel, director of heart transplantation. he said in a statement at New York Presbyterian Church. “We are encouraged by our experience using the FIRE1 System and excited by the prospect of making heart failure management easier and more effective for both patients and clinical teams.”

The FIRE1 device was created to transform heart failure management by allowing patients to monitor and control their own body fluid levels using a consumer-friendly device at home. The vendor said this could be similar to how continuous monitoring of blood sugar levels has revolutionized diabetes treatment. Fluid overload is a classic clinical symptom of heart failure, which affects more than 6 million people in the United States and is the most common cause of hospitalization for people over 65 years of age. Today’s heart failure monitoring technologies do not directly measure fluid volume within the IVC, resulting in measurement delays that do not identify fluid overload early enough.

The FIRE1 system is a small, minimally invasive, implantable sensor designed to accurately identify fluid buildup early when patients can easily be managed without a hospital visit. The device is built into a stent-like structure that expands to hold the monitor in place on her IVC wall, similar to IVC filter placement.