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-Endotronix presents positive results from the PROACTIVE-HF clinical trial for its Cordella pulmonary artery sensor
NAPERVILLE, Ill., March 6, 2024 /PRNewswire/ -- Endotronix, Inc., a private company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medical technology, presented results 6 months of its pivotal PROACTIVE-HF trial. PROACTIVE-HF evaluated the company's investigational Cordella pulmonary artery (PA) sensor in patients with New York Heart Association (NYHA) class III heart failure at risk for congestion. The trial met primary safety and efficacy endpoints and demonstrated a remarkably low rate of hospitalizations for heart failure, as well as showing a clinically significant improvement in patient quality of life, increased physical activity, and improvement in NYHA functional class. The company previously announced the submission of its PMA application, which included the test results. Dr. Liviu Klein presented the results today during a breaking session at the Cardiovascular Research Foundation's Heart Failure Technology and Therapeutics (THT) conference in Boston, MA.
To read the full results of the PROACTIVE-HF trial, click here.
"These results are very encouraging and provide strong evidence in favor of treating heart failure using AP pressure-guided therapy, coupled with vital signs data, to remotely optimize guideline-directed medical therapy and improve cardiac outcomes. heart failure," said Dr. Klein, section chief of advanced heart failure, mechanical circulatory support, pulmonary hypertension and heart transplantation at the University of California, San Francisco and national principal investigator of the PROACTIVE-HF trial. "Cordella offers a novel patient-friendly system that includes a portable AP pressure reader and allows patient visibility to health data. In my opinion, these key differentiators helped drive high levels of patient engagement and supported to make decisions about healthy lifestyles. Combined with the doctors' specific medication adjustments using the whole system view of the patient's health status, we achieved excellent results for patients overall and compared to the same period before the sensor implant".
In the prospective multicenter trial, 528 patients with NYHA class III heart failure were implanted at 75 centers in the US and Europe. More than half of the implanters were heart failure specialists and the trial showed high rates of patient compliance (>6 average Cordella presentations per week) and physician participation (>2 average reviews per week). Results from a single 6-month arm met primary safety and efficacy endpoints as well as several clinically significant secondary efficacy endpoints.
The PROACTIVE-HF results are consistent with previously reported clinical data for the Cordella PA sensor, including published 12-month results from the SIRONA 2 trial.
"These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide the best care for heart failure patients," said Harry Rowland, CEO and co-founder of Endotronix. . "We believe that proactive, comprehensive care with Cordella improves the lives of patients living with heart failure and PROACTIVE-HF provides compelling evidence to support this new approach to delivering impactful remote care. With commercial launch planned for later this "This year, we look forward to supporting physicians to help heart failure patients lead fuller, more active lives."
Additionally, Endotronix continues to expand its evidence-based clinical base for Cordella with the expansion of the PROACTIVE-HF 2 clinical trial to market.
About EndotronixEndotronix innovates at the intersection of Medtech and Digital Health to improve care for people living with heart failure (HF). Cordella's comprehensive solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery pressure (PA) sensor that directly measures the leading indicator of congestion, allowing for early, targeted therapy. Cordella HF System is a patient health management platform that combines comprehensive vital signs data from non-invasive devices to support physician-patient engagement and care decisions. By combining trending insights, versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the heart failure continuum. Learn more at www.endotronix.com.
The Cordella Pulmonary Artery Sensor System is an investigational device and is not currently approved for clinical use in any geographic location. CAUTION: Investigational device. Limited by federal (or United States) law to use for research purposes. Exclusively for Clinical Research. The sensorless Cordella HF system is available for commercial use in the US and EU.
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