LISLE, Ill., April 4, 2023 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced that its pivotal study PROACTIVE -HF successfully completed the registration. Designed to evaluate the safety and efficacy of the Cordella™ pulmonary artery (PA) sensor, the data will support the application for premarket approval (PMA) for market access in the United States.
"Building on a strong evidence base in favor of PA pressure-guided therapy, the PROACTIVE-HF trial is investigating a more complete clinical picture for both clinicians and patients," said Liviu Klein, MD, chief of Section of Advanced Heart Failure, Mechanics Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California, San Francisco and National Principal Investigator of the PROACTIVE-HF trial. "Cordella provides daily BP and vital sign data to help clarify a patient's clinical status. In addition, we are seeing high levels of engagement and lifestyle changes as a result of patients having visibility into their own data. We look forward to share the results of the study in the coming months.
In particular, the first global investigational device exemption (IDE) study for the management of BP pressure-guided heart failure, PROACTIVE-HF, enrolled more than 450 patients in the United States, Ireland, and Belgium. Primary endpoints for the single-arm, multicenter trial include mortality and heart failure hospitalizations, as well as device safety. The company expects to report primary endpoint data from the trial in the first half of 2024.
"I would like to congratulate all of our clinical partners on their tremendous effort to complete enrollment in PROACTIVE-HF. Their hard work and dedication are key to improving outcomes and expanding patient access, and we appreciate their continued commitment to this trial." said Harry Rowland, CEO and co-founder of Endotronix.
About Endotronix Endotronix innovates at the intersection of Medtech and Digital Health to improve care for people living with heart failure (HF). Cordella's end-to-end solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella PA sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing for early and targeted therapy. The Cordella HF system is a patient health management platform, combining comprehensive vital sign data from non-invasive devices to support physician and patient engagement and care decisions. By combining trend insights, the versatile and scalable Cordella improves current clinical practice and supports guideline-based care across the HF continuum. Learn more at www.endotronix.com.
The Cordella™ PA Pressure Sensor System is an investigational device and is not currently approved for clinical use in any geography. CAUTION: research device. Limited by federal (or United States) law to research use. Exclusively for Clinical Research. The Cordella HF system, without the sensor, is available for commercial use in the US and EU.
Cautionary Statement Regarding Forward-Looking Statements This press release may contain predictions, estimates or other information that could be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.
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