Endotronix has presented first-in-human data of the Cordella pulmonary artery pressure sensor System at the 2019 American Heart Association (AHA) Scientific Sessions (16–18 November, Philadelphia, USA). Data were presented by Wilfried Mullens (Hospital Oost-Limburg, Genk, Belgium).
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, Endotronix said in a release. The study included 15 patients across two European sites, Mullens in Belgium and Faisal Sharif (National University of Ireland, Galway, Ireland).
Study findings showed that 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, Endotronix noted.
“Chronic heart failure patients too frequently have cycles of decompensation and hospitalisation that negatively impact patient outcomes and drive up treatment costs. Recent data shows that using pulmonary artery pressure-guided therapy with this population keeps them healthier and out of the hospital,” stated Mullens. “The Cordella System is an elegant solution that integrates a PA 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.”
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 US (PROACTIVE-HF IDE Trial).