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Endotronix, Inc. 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.

Endotronix, Inc. presented 6-month results from its PROACTIVE-HF pivotal trial. PROACTIVE-HF evaluated the company’s investigational Cordella Pulmonary Artery (PA) Sensor in New York Heart Association (NYHA) class III HF patients at risk of congestion.

Endotronix, Inc. 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).

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy.

Endotronix, Inc. today announced its PROACTIVE-HF pivotal study successfully completed enrollment. Designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S.

Endotronix, Inc. today announced positive 12-month data from the SIRONA 2 clinical trial that demonstrated long-term use of the Cordella Pulmonary Artery (PA) Sensor was associated with significant improvements in patient quality-of-life metrics and low HF hospitalization and death (HFH/D) event rates for New York Heart Failure (NYHA) class III patients.

Endotronix, Inc. announced plans to relocate and expand their headquarters in Naperville, Illinois to support the full U.S. commercial launch of its Cordella™ Heart Failure System and Pulmonary Artery Sensor, pending pre-market approval of the sensor by the U.S. Food & Drug Administration.

Endotronix, Inc. announced positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella™ Pulmonary Artery Pressure Sensor System in New York Heart Association class III heart failure patients.

Endotronix, Inc., today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor.

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment of seasoned medical device industry executive Dan Dearen to its Board of Directors.