Endotronix Gets FDA’s OK to Begin Pulmonary Artery Pressure Sensor Trial
The FDA has given Endotronix the go-ahead to initiate a pivotal trial for its Cordella Pulmonary Artery Pressure Sensor System.
The randomized, multi-center trial will gauge the device’s safety and efficacy in over 950 patients at as many as 60 U.S. sites. It will study the sensor in class III heart failure patients, who experience noticeable limitation in activity due to their symptoms.
The sensor is designed to be used with the company’s Cordella Heart Failure system, which records a patient’s health status at home with a remote management platform and securely shares it with their physician.