Endotronix, Inc, a medical technology and digital health company dedicated to advancing the treatment of heart failure (HF),announced the end of recruitment of the PROACTIVE-HF pivotal study was successful. Designed to evaluate the safety and efficacy of the Cordella PA sensor for the pulmonary artery, the data will support the US premarket approval application.
“Building on a strong evidence base supporting PA pressure-guided therapy, the PROACTIVE-HF trial is investigating a more complete clinical picture for clinicians and patients,” commented Liviu Klein, MD, Section Chief, Advanced Unit of Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplantation at the University of California, San Franciscoand national principal investigator of the PROACTIVE-HF trial. “Cordella provides daily blood pressure and vital signs data to help clarify the patient’s clinical status. Additionally, we are seeing high levels of engagement and lifestyle changes due to data visibility for patients. We look forward to sharing the results of the study over the coming months.”
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In particular, the world’s first investigational device exemption study for PA pressure-guided HF management, PROACTIVE-HF enrolled over 450 patients in the United States, Ireland and Belgium. Key endpoints of the single-arm, multicenter trial include heart failure mortality and hospitalizations, as well as device safety. The company expects to report primary endpoint data for the trial in the first half of 2024.
“I would like to commend all of our clinical partners for their tremendous efforts to enroll in PROACTIVE-HF. Their hard work and dedication are essential to improving outcomes and expanding patient access, and we appreciate their continued commitment to this trial,” said Harry Rowland, CEO and co-founder of Endotronix.
Endotronix innovates at the intersection of medical technology and digital health to improve care for people with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella PA sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the primary indicator of congestion, enabling early and targeted therapy. The Cordella HF System is a patient health management platform that combines comprehensive vital signs data from noninvasive devices to support patient-clinician engagement and care decisions.
SOURCE: PR Newswire