Endotronix said it received Premarket Approval (PMA) from the FDA for its Cordella Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The Cordella platform is a PA pressure-guided platform offering patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.
Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.
In addition, Cordella enables:
- Seated PA pressure measurements, preferred by most patients, with a handheld reader.
- Patient visibility into key health trends to support healthy lifestyle changes.
- Secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care.
- Reimbursement for implantation and ongoing management through existing reimbursement pathways.
Endotronix will launch Cordella in the U.S. later this year. The company also shared that they have submitted a dossier for CE Mark review and expect a decision on European market access in 2025.
