A press release reports that the first patient has been enrolled in a prospective, multicentre trial (SIRONA II) of a pulmonary artery pressure sensor system (Cordella sensor, Endotronix), the aim of which is to valuate safety and efficacy of the system in support of its CE mark submission. Wilfried Mullens (Ziekenhuis Oost Limburg, Genk, University Hasselt, Hasselt, Belgium) enrolled the first SIRONA II trial patient at the Hospital Oost-Limburg in Genk, Belgium.
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 hospitalisations, device performance, and patient quality of life.
The Cordella sensor is an integrated component of the Cordella heart failure system, which includes a remote patient management platform with tools to securely collect and share daily patient data with healthcare providers. Together, the press release states, 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.
Mullens comments: “The current treatment model for chronic heart failure is reactive and costly. Clinical data demonstrates that pulmonary artery pressure is the best indicator for early detection and proactive care of heart failure decompensation. In my experience, the Cordella sensor provides reliable pulmonary artery pressure measurements that when combined with daily patient data presents a comprehensive clinical picture so I can effectively manage my heart failure patients remotely.”
Katrin Leadley, chief medical officer of Endotronix, says: “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. It is the next step in our robust clinical programme, which also includes a pivotal IDE trial for the implantable sensor, PROACTIVE-HF, set to begin later this year in the USA”
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 USA and EU and is currently in cardiology centres across the USA.