Medical technology company Endotronix has unveiled positive data from SIRONA trial of Cordella pulmonary artery (PA) pressure sensor system (Cordella Sensor).
The first-in-human clinical study was conducted for 90 days, enrolling 15 patients at two European sites, Hospital Oost-Limburg in Genk, Belgium, and the National University of Ireland (NUI) in Galway, Ireland.
The results from the study demonstrated encouraging safety results with zero Device Related System Complications (DSRC), high patient compliance with daily remote measurements of vital signs and PA pressure using the implanted Cordella Sensor.
In addition, the study has reached primary end point with no difference in measured mean PA pressure for the Cordella Sensor and the reference catheter at 90 days.
Wilfried Mullens from Hospital Oost-Limburg in Genk, Belgium said: “Chronic heart failure patients too frequently have cycles of decompensation and hospitalization that negatively impact patient outcomes and drive up treatment costs. Recent data shows that using PA pressure-guided therapy with this population keeps them healthier and out of the hospital.
“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.”
Cordella Sensor is under clinical investigation in Europe and the US
Endotronix’ Cordella heart failure system is intended to help patients suffering from chronic heart failure to stay out of the hospital with streamlined care and remote medication titration.
The system is set to offer a complete health status of the patient at home with tools that securely collect health related data and share with healthcare providers for trend-based management.
The company said that the Cordella Sensor has been designed to easily integrate pulmonary artery (PA) pressure data into the Cordella system.
In addition, the system and sensor together will deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.
The Cordella Sensor is not indicated for commercial use in any country and is under clinical investigation in Europe and the US. The system is an investigational device and its use has been limited by the US Federal Law.
Endotronix chief medical officer Katrin Leadley said: “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 groundbreaking IDE trial, PROACTIVE-HF, which will begin enrollment in the U.S. later this year.
“Designed to provide the highest level of clinical evidence for PA pressure-guided therapy, PROACTIVE-HF will support U.S. market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).”
