
Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes.
The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of congestion. It met primary safety and efficacy endpoints and demonstrated a markedly low rate of HF hospitalizations. Endotronix also reported a clinically significant improvement in patient quality of life, increased physical activity and improvement in the NYHA functional class.
Positive results from PROACTIVE-HF follow the company’s premarket approval (PMA) application to the FDA for Cordella in January. Dr. Liviu Klein presented the results at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. In a news release, Klein said the “encouraging” results provide strong evidence in favor of using this method to improve HF outcomes.
“Cordella offers a novel patient-friendly system that includes a handheld PA pressure reader and allows patient visibility to health data. In my opinion, these key differentiators helped drive high levels of engagement for patients and supported them to make healthy lifestyle choices,” Klein said. “Combined with the clinicians’ targeted medication adjustments using the system’s comprehensive view of patient health status, we achieved great patient outcomes overall and when compared to the same period before sensor implant.”
More about the Endotronix study results
The trial implanted 528 NYHA Class III HF patients across 75 U.S. and European sites. Results showed 99.2% freedom from device- or system-related complications and 99.8% freedom from PA sensor failure. Endotronix completed enrollment for the trial in April 2023.
Results fell in line with previously reported clinical data for Cordella, including 12-month data from the SIRONA 2 trial.
The PROACTIVE-HF results are consistent with previously reported clinical data for the Cordella PA Sensor, including the published 12-month results from the SIRONA 2 trial.
Endotronix plans to continue extending its evidence-based clinical foundation for Cordella. It has enrollment underway for the market-expanding PROACTIVE-HF 2 clinical trial as well.
“These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide best-in-class care for heart failure patients,” said Harry Rowland, CEO and co-founder of Endotronix. “We believe proactive, comprehensive care with Cordella improves the lives of patients living with heart failure and PROACTIVE-HF provides compelling evidence to support this new approach to impactful remote care delivery. With commercial launch expected later this year, we look forward to supporting clinicians in helping heart failure patients lead more full and active lives.”