NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., 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 innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home. Its user-friendly 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.
About Endotronix
Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.
The Cordella Pulmonary Artery Sensor System is an investigational device and is not currently approved for clinical use in any geography. CAUTION - Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for Clinical Investigation. The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.
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