Endotronix today announced it received FDA premarket approval for its Cordella PA Sensor System. The Naperville, Illinois=based company designed the Cordella Pulmonary Artery (PA) Sensor System to treat New York Heart Failure (NYHA) class III heart failure patients. It is the first PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to help guide therapeutic management.
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“This approval is very exciting and has the potential to transform care for HF patients. 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,” said Dr. Liviu Klein, section chief of advanced heart failure, mechanical circulatory support, pulmonary hypertension and heart transplant at the University of California San Francisco.
Cordella delivers daily PA pressure and other vital data through an implantable sensor. Its user-friendly and noninvasive health tools help HF clinicians manage care remotely. The system’s information guides clinical decision-making and medication dosing while allowing for the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes, according to Endotronix.
The FDA approval was based on data from the company’s Proactive-HF trial, which demonstrated a low 0.159 rate of heart failure hospitalizations and all-cause mortality at six months.
“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,” said Klein, the national principal investigator of the Proactive-HF trial.
Other features of Cordella include seated PA pressure measurements with a handheld reader; patient visibility into key health trends to support healthy lifestyle changes; secure messaging between clinical teams, patients and caregivers to support remote care; and reimbursement for implantation and ongoing management through existing reimbursement pathways.
“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,” CEO Harry Rowland said in a news release. “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.”
The company plans to launch Cordella in the U.S. later this year. It has also been submitted for CE mark review, and a decision on European market access is expected in 2025.
