Company also announces publication of the PROACTIVE-HF trial design rationale, the first global IDE trial for PA pressure-guided heart failure management, in the Journal of Cardiac Failure
LISLE, Ill., Sept. 30, 2022 /PRNewswire/ -- Endotronix, Inc., a privately-held digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced implantation of the 400th Cordella Pulmonary Artery (PA) Pressure Sensor. The milestone includes successful implants across the company's completed European trials, SIRONA First-in-Human and SIRONA 2, as well as the currently enrolling global investigational device exemption (IDE) trial, PROACTIVE-HF. Designed to unlock the power of comprehensive HF management, PROACTIVE-HF is evaluating a multisystem care delivery model that includes daily PA pressure and vital sign measurements as well as self-reported symptoms to optimize remote care.
Additionally, the PROACTIVE-HF trial design manuscript was published today in the Journal of Cardiac Failure. The peer-reviewed publication provides the rationale of the trial design, explains the recent switch to a single arm study and describes key advantages of the Cordella Heart Failure System and Sensor relative to commercially available solutions. Lead author and National Principal Investigator of the PROACTIVE-HF trial, Dr. Liviu Klein shared, "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." Dr. Klein also serves as Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at the University of California San Francisco.
"As we push towards full enrollment in the study, the momentum and energy from our phenomenal clinical partners is fantastic," stated Harry Rowland, CEO of Endotronix. "This recent publication expands our clinical foundation. The Cordella System and Sensor, together, provide a meaningful advancement in heart failure management that we believe will help clinicians achieve better patient engagement and outcomes."
Providing a more comprehensive approach to patient management, the Cordella Heart Failure System is designed to enable scalable remote heart failure management that combines patient engagement, GDMT uptitration, and diuretic optimization to improve care and prevent worsening heart failure. The platform consists of a patient management system that securely collects daily vital sign measurements and self-reported symptoms, coupled with a seamlessly integrated, next-generation implantable PA pressure sensor, which provides PA pressure data. Combined, this trended information is accessed through a best-in-class clinician portal to inform decisions of when to proactively titrate medications and improve patient care between office visits, all while supporting reimbursement for care delivery activities.
PROACTIVE-HF is the first global IDE clinical trial for PA pressure-guided heart failure management. Due to complete enrollment in early 2023, PROACTIVE-HF will support U.S. regulatory approval and market access of the sensor. The single-arm 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. Recently published positive clinical results from SIRONA 2, the 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.
These achievements follow a recent round of financing by the company that secured funding through pre-market approval (PMA) of the sensor.
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. Learn more at www.endotronix.com.
The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella Sensor is currently under clinical investigation and is not currently available for commercial use in any geography.
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