Endotronix Continues PROACTIVE-HF Global IDE Trial of Cordella Pulmonary Artery Pressure Sensor

September 30, 2022—Endotronix, Inc. announced updates in the clinical development of the Cordella pulmonary artery (PA) pressure sensor. The Cordella sensor is currently under clinical investigation and is not currently available for commercial use in any geography. The company advised that the sensor has been implanted in 400 patients in investigational-use procedures. The Cordella system, without the sensor, is available for commercial use in the United States and European Union.

Endotronix continues to enroll patients in the PROACTIVE-HF global investigational device exemption (IDE) trial. PROACTIVE-HF is evaluating the company’s Cordella multisystem care delivery model that includes daily PA pressure and vital sign measurements as well as self-reported symptoms to optimize remote care. The trial, which is due to complete enrollment in early 2023, will support FDA approval and United States market access of the sensor.

The single-arm PROACTIVE-HF study will enroll 450 New York Heart Association (NYHA) class III heart failure patients at approximately 100 sites worldwide and will assess the safety and efficacy of the Cordella Sensor. The company commenced enrollment in February 2020.

The company noted that the PROACTIVE-HF trial design was published by Jason L. Guichard, MD, et al in the Journal of Cardiac Failure. The investigators provided the rationale for the trial design, explained the recent switch to a single-arm study, and described key advantages of the Cordella HF system and sensor relative to commercially available solutions.

Liviu Klein, MD, the article’s senior author, serves as the National Principal Investigator of the PROACTIVE-HF trial. Dr. Klein is Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at the University of California San Francisco.

Dr. Klein commented in the company’s press release, “The heart failure community is embracing the benefits of PA pressure-guided management. The comprehensive Cordella system and sensor builds on previous evidence and advances our ability as clinicians to provide guideline-directed medical therapy (GDMT) to improve patient outcomes. We are proud to be part of this journey of demonstrating sustained positive patient outcomes through PROACTIVE-HF.”

In January 2022, the company announced that the FDA approved the shift to a single-arm design for the trial.

Additionally, Endotronix advised it had completed the 15-patient SIRONA First-in-Human (FIH) and the 81-patient SIRONA 2 European clinical trials.

According to the company, the positive clinical results from the SIRONA 2 CE Mark clinical trial demonstrated safe and effective comprehensive HF management with low HF hospitalization rates, improved patient functional status as measured by NYHA classification, consistently high patient compliance with daily measurements, and an overwhelming patient preference for seated PA pressure readings instead of lying flat.

Data from the SIRONA 2 trial showing the Cordella PA sensor system met all primary safety and efficacy endpoints at 90 days were presented at a late-breaking session at the European Society of Cardiology’s Heart Failure Association 2022 conference held May 21-24 in Madrid, Spain. On June 10, Faisal Sharif, MD, et al published the findings online in ESC Heart Failure.

In May 2020, Professor Wilfried Mullens, PhD, et al published the findings from the SIRONA FIH study in the European Journal of Heart Failure. Prof. Mullens presented the findings at the 2019 American Heart Association Scientific Sessions.

According to Endotronix, the Cordella HF system is designed to provide scalable remote HF management that combines patient engagement, GDMT uptitration, and diuretic optimization to improve care and prevent worsening HF.

The platform consists of a patient management system that securely collects daily vital sign measurements and self-reported symptoms, coupled with an integrated, next-generation implantable PA pressure sensor that provides PA pressure data. This trended information is accessed through a clinician portal to inform decisions on when to proactively titrate medications and improve patient care between office visits. The system supports reimbursement for care delivery activities, noted the company.