Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure
- Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions.
- Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.
NAPERVILLE, Ill., June 24, 2024 /PRNewswire/ — Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.
