Endotronix Cordella PA Sensor System Receives FDA Approval

June 24, 2024—Endotronix, Inc. announced it received FDA premarket approval (PMA) of the company’s Cordella pulmonary artery (PA) sensor system for the treatment of New York Heart Failure class III heart failure (HF) patients.

Cordella, which consists of the now PMA-approved Cordella PA sensor and the commercially available Cordella HF system, enables comprehensive HF management in the home using PA pressure and noninvasive vital sign data to improve care decisions. Endotronix will launch Cordella in the United States later this year.

The Cordella HF system is available in the United States and Europe. In Europe, the Cordella PA sensor system is only available for investigational use. The company noted that it has submitted a dossier for CE Mark review and expects a decision on European market access in 2025.

According to the company, the Cordella platform is a PA pressure-guided platform providing comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.

The device’s implantable sensor with user-friendly, noninvasive health tools are used to send data 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 to reduce congestion and improve outcomes.

The company noted that regulatory approval of the device was based on the PROACTIVE-HF trial, which demonstrated a low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.

Liviu Klein, MD, National Principal Investigator of the PROACTIVE-HF trial, presented the results during a late-breaking session at THT 2024, the Cardiovascular Research Foundation’s Technology and Heart Failure Therapeutics conference held March 4-6 in Boston, Massachusetts.

“This approval is very exciting and has the potential to transform care for HF patients,” commented Dr. Klein in the company’s press release. “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.”

Dr. Klein continued, “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.”

Dr. Klein is Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco in San Francisco, California.