Endotronix, a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).
Cordella is an HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home. Its devices securely transmit daily health information to the managing clinician, supporting optimal dosing of guideline-directed medical therapy (GDMT) to reduce congestion and engaging patients with trended health data to enable healthy lifestyle choices.
"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," stated 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."
This news follows the company's prior announcement that PROACTIVE-HF, the company's 450-patient investigational device exemption (IDE) trial, completed enrollment. The company expects to share primary endpoint results from the trial in the first half of 2024.