Fire1’s FUTURE-HF FIH Study Expanded to Ireland

May 30, 2024—Fire1, a medical device company headquartered in Dublin, Ireland, announced that the first patient in Ireland has been successfully implanted with its Fire1 system for remote heart failure (HF) monitoring.

The procedure in Ireland is part of the FUTURE-HF first-in-human (FIH) clinical investigation of the Fire1 system in HF patients. The study will assess the Fire1 device to improve outcomes in patients with heart failure.

According to the company, the implantation was performed by Professor Faisal Sharif, MBBS, PhD, at University Hospital Galway (UHG) in Galway, Ireland. Prof. Sharif is Professor of Interventional Cardiology and Translational Medicine at UHG.

“We are delighted to bring this new, transformative technology to Ireland for the first time,” commented Prof. Sharif in Fire1’s press release. “The procedure was very straightforward, minimally invasive, and the patient was confident using the Fire1 system and taking the readings.”

Prof. Sharif continued, “The data we will get from this patient will give a new window into HF management and has the potential to dramatically improve our understanding of this patient’s condition, and to enable proactive changes in medications that will keep them healthy and at home. We hope to implant further patients at UHG while recruitment is still active.”

Fire1 aims to enable HF patients to monitor and control their fluid volume themselves with a device at home, similar to how continuous glucose monitoring transformed diabetes care.

The company stated that the Fire1 sensor is implanted into the inferior vena cava (IVC) and continuously measures the size of the IVC, giving a marker of the amount of fluid in the body. The patient wears a belt reader around the abdomen for approximately one minute a day to take a reading from the sensor. The data is sent to the patient’s clinical team at the hospital. The system is designed to alert whenever the patient’s condition deteriorates. The Fire1 system is currently undergoing global clinical trials to test the safety and effectiveness of the technology.

In Ireland, fluid overload, a clinical feature of HF, affects approximately 90,000 patients in Ireland and is a leading cause of high admission and re-admissions hospitalizations rates, noted the company.