FIRE1 Showcases Breakthrough Heart Failure Monitoring System at HFSA 2025 with Late-Breaking Science Presentation
FIRE1, a connected medical device solutions company pioneering innovative approaches in heart failure care, announced that results from its FUTURE-HF clinical trial program were featured in the Late-Breaking Science plenary session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025. The prestigious session took place on Sunday, September 28, from 9:00–10:30 a.m. CT, underscoring the growing recognition of FIRE1’s work in advancing heart failure management technologies.
The presentation introduced the Norm™ investigational heart failure management system and the NORM Score, a novel individualized congestion index designed to transform how patients and clinicians detect and manage worsening heart failure. The data presented drew upon two clinical trials—FUTURE-HF and FUTURE-HF2—which evaluated FIRE1’s implantable inferior vena cava (IVC) sensor technology and its role in early identification of congestion.
Simultaneous with the HFSA presentation, a companion manuscript titled “Derivation of a Personalized Congestion Score Using a Chronic Implantable Inferior Vena Cava Management System in Heart Failure: An Analysis from the FUTURE-HF Trial Portfolio” was published in the Journal of Cardiac Failure, further validating the clinical significance of the findings.
Addressing an Unmet Need in Heart Failure
Heart failure remains a leading cause of hospitalization worldwide, with millions of patients experiencing recurrent episodes of congestion that result in emergency department visits, hospital stays, and diminished quality of life. While current management strategies rely heavily on symptom monitoring, lab tests, and intermittent imaging, these approaches often detect worsening heart failure only after substantial physiological deterioration has occurred.
Congestion, characterized by fluid buildup, is a key driver of hospitalization in heart failure patients. However, traditional tools such as weight monitoring or blood biomarkers often fail to provide adequate early warning of decompensation. Clinicians and patients alike face significant challenges in identifying subtle changes that signal worsening heart function before critical events unfold.
Against this backdrop, FIRE1’s Norm System introduces an entirely new paradigm. By leveraging a chronic implantable sensor placed in the inferior vena cava—a large vein that returns blood from the lower body to the heart—the system provides daily ambulatory measurements of IVC dynamics, enabling physicians and patients to identify congestion trends earlier and more accurately than conventional methods.
The FUTURE-HF Clinical Trial Portfolio
The FUTURE-HF and FUTURE-HF2 studies formed the foundation for FIRE1’s late-breaking presentation. These trials were designed to evaluate the safety, feasibility, and clinical utility of the FIRE1 implantable IVC sensor in patients with chronic heart failure.
Central to the analysis was the development of the NORM Score, an individualized congestion index derived retrospectively from sensor data collected during the two studies. Because the IVC is highly compliant and sensitive to changes in venous pressure, it offers a unique vantage point for detecting early signs of fluid overload, often before traditional measures such as pulmonary pressures or natriuretic peptides show significant changes.
Key Findings: The Norm Score’s Predictive Power
The analysis presented by Marat Fudim, MD, MHS, Advanced Heart Failure Cardiologist at Duke Health in Durham, NC, highlighted several compelling findings:
- Strong correlation with NT-proBNP: Elevated Norm Scores were significantly associated with increased levels of NT-proBNP, a well-established biomarker of heart failure severity (β = 5.64; 95% CI: 3.23–8.05; p < 0.001).
- Early and sensitive detection of events: The Norm Score predicted worsening heart failure events with a 92.6% sensitivity and achieved a C-statistic of 0.83, reflecting strong discriminative ability.
- Low unexplained alert rate: The system generated only 0.57 unexplained alerts per patient-year, minimizing the risk of unnecessary interventions or patient anxiety.
- High odds ratio for hospitalization risk: Patients with Norm Scores out of range for 5 out of 7 days had an 18.0-fold higher odds (95% CI: 3.5–93.8) of hospitalization for heart failure.
Collectively, these findings demonstrate that the Norm Score provides a reliable and actionable early-warning signal of decompensation, offering both patients and clinicians an opportunity to intervene before a crisis occurs.
Transforming Heart Failure Management
One of the most striking aspects of the FIRE1 approach is its potential to empower patients through physician-directed self-management. Unlike traditional monitoring tools that often require clinical interpretation alone, the Norm System is being designed to deliver actionable insights directly to patients under physician guidance.
By alerting patients to subtle congestion changes, the technology supports earlier lifestyle adjustments, medication titration, or physician contact, potentially reducing the need for hospitalization. At the same time, by filtering alerts to those most likely to be clinically meaningful, the Norm Score reduces the burden on healthcare staff and allows physicians to focus their attention where it is needed most.
“The Norm System represents a shift from reactive to proactive care,” said Dr. Fudim during his presentation. “By continuously monitoring a key physiological parameter and translating it into a personalized congestion score, we can give patients and providers the tools to stay ahead of heart failure events.”
