Endotronix Boasts Positive Data for Cordella Pulmonary Artery Sensor

Endotronix presented six-month results from its PROACTIVE-HF pivotal trial, which is evaluating the company’s investigational Cordella pulmonary artery (PA) sensor for New York Heart Association (NYHA) class III HF (heart failure) patients at risk of congestion.
 
The Cordella heart failure system integrates data from a wireless, implantable PA sensor using a handheld patient reader as well as data from non-invasive physiologic sensors.
 
The trial met its primary endpoints, with a low rate of HF hospitalizations. It also showed improvements in quality of life, increased physical activity, and NYHA functional class.
 
The trial implanted 528 patients across 75 U.S. and European sites. The trial showed high rates of patient compliance and clinician engagements along with significant secondary efficacy endpoints in device/system-related complications (99.2% freedom) and sensor failure (99.8% freedom).
 
“Cordella offers a novel patient-friendly system that includes a handheld PA pressure reader and allows patient visibility to health data,” said Dr. Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. “In my opinion, these key differentiators helped drive high levels of engagement for patients and supported them to make healthy lifestyle choices. 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.”
 
In October 2023, Endotronix gained investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its PROACTIVE-HF2 study, which will use Cordella for PA pressure-guided therapy in 1,500 patients.
 
“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 Endotronix co-founder and CEO Harry Rowland. “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.”
 
The company submitted its PMA application to the FDA for Cordella in January 2024.

More info on the PROACTIVE-HF trial