LISLE, Ill., 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.