Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes.
The Cordella system delivers proactive PA pressure data and non-invasive vital health data for at-home HF management. Its user-friendly devices securely transmit daily health information to the managing clinician as well. This supports the optimal dosing of guideline-directed medical therapy, reducing congestion and engaging patients.
In April, Endotronix completed enrollment in its Proactive-HF pivotal study, which supports its application for FDA premarket approval. 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.
“A cornerstone for managing NYHA class III heart failure patients, PA pressure-guided therapy combined with strong patient engagement and integration of daily vital signs is an exciting advancement that has the potential to improve outcomes,” said Harry Rowland, CEO and co-founder of Endotronix. “Submitting this PMA application is a significant regulatory milestone and brings us one step closer to the expected commercial launch of the Cordella Sensor in the second half of this year.”