Endotronix Enrolls First Patient in SIRONA II CE Mark Trial
Study to support European clearance of Cordella™ Pulmonary Artery Sensor System for treatment of patients with chronic heart failure
LISLE, Illinois, July 15, 2019 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe. The 60-patient study will evaluate safety and efficacy of the Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in support of its CE Mark submission.
Cardiologist Prof. Dr. Wilfried Mullens enrolled the first SIRONA II trial patient at the Hospital Oost-Limburg in Genk, Belgium. An investigator in the SIRONA I First-in-Human study, Prof. Dr. Mullens commented, "The current treatment model for chronic heart failure is reactive and costly. Clinical data demonstrates that pulmonary artery (PA) pressure is the best indicator for early detection and proactive care of heart failure decompensation," Prof. Dr. Mullens continues, "In my experience, the Cordella Sensor provides reliable PA pressure measurements that when combined with daily patient data presents a comprehensive clinical picture so I can effectively manage my heart failure patients remotely."
Enrolling patients at up to eight European sites, the open-label SIRONA II CE Mark trial is designed to show safety and efficacy of the Cordella Sensor for the management of New York Heart Association (NYHA) Class III heart failure patients. Key secondary endpoints of the trial include rate of heart failure hospitalizations, device performance, and patient quality of life.
"SIRONA II builds on the success of our First-in-Human trial and expands our experience with the Cordella Sensor as we progress towards receiving our CE Mark," stated Katrin Leadley, MD, Chief Medical Officer of Endotronix. "It is the next step in our robust clinical program, which also includes a pivotal IDE trial for the implantable sensor, PROACTIVE-HF, set to begin later this year in the U.S."
The Cordella Sensor is an integrated component of the comprehensive Cordella™ Heart Failure System (Cordella System), which also includes a remote patient management platform with easy-to-use tools to securely collect and share daily patient data with healthcare providers. Together the Cordella System and Sensor aim to proactively provide healthcare providers with the information they need to improve patient care between office visits while supporting reimbursement for care delivery activities. The system enables remote titration of medication and streamlines patient management to help keep patients out of the hospital.
The Cordella Sensor is an investigational device and is not available for commercial use in any geography. 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.
About Endotronix
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.
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