US-based medical equipment maker Endotronix has received the US Food and Drug Administration (FDA) premarket approval (PMA) for its Cordella Sensor System.
The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures PA, the indicator of congestion, allowing early, targeted therapy.
It is indicated for patients with New York Heart Failure (NYHA) class 3 heart failure (HF).
The FDA approval was based on the PROACTIVE-HF trial, in which Cordella showed a significantly low rate (0.159) of heart failure hospitalisation and all-cause mortality at 6 months.
Endotronix said that Cordella is the first and only PA pressure-guided platform to provide complete patient management using daily PA pressure and vital signs from home.
PROACTIVE-HF trial national principal investigator Liviu Klein said: “Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits.
“PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes.
“In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”
The Cordella platform is designed to provide daily PA pressure and other vital data through an implantable sensor and user-friendly, non-invasive health tools.
It guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy to reduce congestion and improve outcomes.
Cordella also enables Seated PA pressure measurements, preferred by most patients, with a handheld reader, along with patient visibility to support healthy lifestyle changes.
The system facilitates secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care, and is backed by reimbursement for implantation.
Endotronix has submitted a dossier for CE Mark review, expecting a decision on European market access in 2025, and plans to launch Cordella in the US later this year.
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.”
