The US Food and Drug Administration (FDA) has granted Endotronix’s Cordella sensor Investigational Device Exemption (IDE) for a second multicentre study, meaning the sensor system’s future use could be expanded to more heart failure patients.
Illinois, US-based Endotronix has already tested the implant for pulmonary artery (PA) pressure-guided therapy in New York Heart Association (NYHA) class III heart failure patients. Endotronix has enrolled more than 450 patients in the PROACTIVE-HF trial for this classification, which includes patients who have marked limitation of physical activity and struggle with less than ordinary activities.
The sensor provides heart pressure readings for the Cordella system, a haemodynamic monitoring system commercially available in the US and the EU. The PA pressure sensor system is still only being used in investigational settings.
The FDA’s latest IDE is for a subsequent study, PROACTIVE-HF 2 (NCT05934487), which will evaluate the device for PA pressure-guided therapy in NYHA class II heart failure patients at risk for congestion. Patients in this classification of heart failure have slight limitations in physical activity and struggle with ordinary activities.
Dr Lynne W Stevenson, heart failure specialist at Vanderbilt University Medical Center in Nashville and global principal investigator (PI) of the PROACTIVE-HF 2 clinical trial, stated that the randomised arm will be the first study to compare PA pressure-guided therapy with a telehealth control arm. The telehealth arm involves clinician-direct patient self-management strategy. Endotronix plans to enrol up to 1,500 patients in the US and Europe.
The company demonstrated lower hospitalisation rates and patient-reported positive pulmonary artery pressure management after device implant in the PROACTIVE-HF trial. The PROACTIVE-HF trial met its primary endpoint, with the company preparing data for pre-market approval (PMA) submission to the FDA by the end of 2023.
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The global cardiovascular device market is predicted to be worth $82bn by 2030.
Dr Stevenson said in a statement: “Together these studies help us better understand the impact of pulmonary hypertension on right ventricular function over time and provide guidance on how to scale this important therapy with patient engagement.”