Endotronix has submitted a premarket approval (PMA) application to the US Food and Drug Administration (FDA) for its Cordella pulmonary artery (PA) sensor system.
The Cordella system is designed to enhance the management of HF patients by providing proactive pulmonary artery pressure data and non-invasive vital health information.
Intended to offer comprehensive at-home care, the system enables secure transmission of daily health data to clinicians, facilitating the optimisation of medical therapy and empowering patients to make informed lifestyle choices.
The submission of the PMA application to the FDA marks a significant milestone for Endotronix, following the completion of enrolment for the PROACTIVE-HF trial.
This 450-patient investigational device exemption (IDE) trial evaluated the safety and efficacy of the Cordella System.
Data from this trial was intended to support the PMA application for market access in the US.
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Endotronix is planning to release the primary endpoint results from the PROACTIVE-HF trial in the first half of this year.
Endotronix CEO and co-founder Harry Rowland said: “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.
“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.”
Last year, the FDA granted Endotronix’s Cordella sensor IDE for a second multicentre study, meaning the sensor system’s future use could be expanded to more heart failure patients.
