The US Food and Drug Administration (FDA) has issued premarket approval for Endotronix’s Cordella PA sensor system.
The PA sensor system is designed for treating New York Heart Association class III heart failure patients.
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Said to be the first and only PA pressure-guided platform, Cordella offers comprehensive patient management. It makes use of PA pressure along with vital signs from home to guide therapeutic management, aiming to improve patient outcomes.
Using implantable sensor and non-invasive health tools, the platform provides proactive heart failure management by delivering daily PA pressure and other vital data.
These tools allow clinicians to remotely monitor patients, guiding clinical decision-making and medication dosing.
The system supports the adoption of guideline-directed medical therapy to reduce congestion and enhance patient outcomes.
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By GlobalDataRegulatory approval for the Cordella system was based on the results from the PROACTIVE-HF trial, which showcased a significantly low heart failure hospitalisation rate and all-cause mortality at six months, with a rate of 0.159.
In January this year, the company submitted a premarket approval application to the FDA for the Cordella system.
It offers several features, including seated PA pressure measurements using a handheld reader, patient access to key health trends to encourage lifestyle changes, and secure messaging between the clinical team, patients and caregivers.
Endotronix CEO and co-founder Harry Rowland said: “At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare.
“The FDA’s approval validates this foundational belief and is a major milestone for our company and the field of HF management.
“With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives.”
Endotronix plans to launch the system in the US later this year.
Additionally, the company has submitted a dossier for CE Mark review and anticipates a decision on European market access next year.
