Sam Brusco, Associate Editor06.24.24
Endotronix has earned premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Cordella pulmonary artery (PA) sensor to treat New York Heart Failure (NYHA) class III heart failure patients.
Cordella delivers daily PA pressure and other vital data via an implanted sensor and non-invasive health tools to a managing clinician for remote care. The info can guide decision-making and medication dosing while boosting adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes.
The sensor enables seated PA pressure measurements with a handheld reader. Secure messaging can be done on a tablet between the clinical team, patient, and caregiver. The company also said there’s reimbursement for implantation and ongoing management through existing reimbursement pathways.
Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a 0.159 rate of heart failure hospitalization and all-cause mortality at six months.
The company said it will launch Cordella later this year and it has submitted for CE mark review, expecting a decision in 2025.
"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," said Harry Rowland, CEO and co-founder of Endotronix. "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."
Cordella delivers daily PA pressure and other vital data via an implanted sensor and non-invasive health tools to a managing clinician for remote care. The info can guide decision-making and medication dosing while boosting adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes.
The sensor enables seated PA pressure measurements with a handheld reader. Secure messaging can be done on a tablet between the clinical team, patient, and caregiver. The company also said there’s reimbursement for implantation and ongoing management through existing reimbursement pathways.
Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a 0.159 rate of heart failure hospitalization and all-cause mortality at six months.
The company said it will launch Cordella later this year and it has submitted for CE mark review, expecting a decision in 2025.
"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," said Harry Rowland, CEO and co-founder of Endotronix. "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."