Data presented at the 2019 American Heart Association Scientific Sessions (16–18 November, Philadelphia, USA), a press release reports, confirm the accuracy and safety of the Cordella pulmonary artery (PA) pressure sensor system (Cordella Sensor, Endotronix). The PA sensor system, with the Cordella system, is designed to proactively deliver the information necessary to improve heart failure patient care between office visits and support reimbursement for care delivery activities.
The 90-day results from the first-in-human trial confirm the device safety and accuracy of pressure measurements in the right pulmonary artery using the implanted Cordella Sensor and handheld patient reader. The data were from a study that included 15 patients across two European sites: Mullens (Hospital Oost-Limburg, Genk, Belgium) and Faisal Sharif (National University of Ireland, Galway, Ireland). The results, according to the press release, showed:
- The primary accuracy endpoint was met with no significant difference in measured mean pulmonary artery pressure for the Cordella Sensor and the reference catheter at 90 days.
- The study demonstrated encouraging safety results with zero device related system complications (DSRC) at 90 days.
- High patient compliance (>98%) with daily remote measurements of vital signs and PA pressure throughout the study.
Mullens reports: “Chronic heart failure patients too frequently have cycles of decompensation and hospitalisation that negatively impact patient outcomes and drive up treatment costs. Recent data show that using pulmonary artery pressure-guided therapy with this population keeps them healthier and out of the hospital. The Cordella System is an elegant solution that integrates a pulmonary artery pressure sensor and a comprehensive patient management platform in one. The straightforward sensor implant provides reliable pressure data, while the patient management platform enables a comprehensive clinical picture of the patient that allows my team to make informed therapy decisions and improve outcomes.”
Katrin Leadley, chief medical officer of Endotronix, comments: “The presentation of our first-in-human data at AHA this year is another exciting milestone for the company. This work lays the clinical foundation for our ground-breaking investigational device exemption (IDE) trial, PROACTIVE-HF, which will begin enrolment in the USA later this year. Designed to provide the highest level of clinical evidence for pulmonary artery pressure-guided therapy, PROACTIVE-HF will support US market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).”
The Cordella Sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the USA (PROACTIVE-HF IDE Trial).