Lisle, Illinois-based Endotronix plans for results from the Proactive-HF pivotal study to support its application for FDA premarket approval.
Cordella, an investigational device, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes.
The implantable PA pressure sensor directly measures the leading indicator of congestion, allowing early, targeted therapy. A patient health management platform, it combines comprehensive vital sign data from non-invasive devices to support engagement and care decisions.
Dr. Liviu Klein, section chief of advanced heart failure, mechanical circulatory support, pulmonary hypertension and heart transplant at the University of California San Francisco, serves as national principal investigator for Proactive-HF. Klein said the trial investigates “a more comprehensive clinical picture for both clinicians and patients.”
Endotronix said that Proactive-HF enrolled more than 450 patients across the U.S., Ireland and Belgium. The study’s primary endpoints include mortality and HF hospitalizations as well as device safety. Endotronix expects to report primary endpoint data in the first half of 2024.
“I would like to congratulate all our clinical partners on their tremendous effort to complete enrollment for PROACTIVE-HF. Their hard work and dedication are key 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.