November 17, 2019
SIRONA Trial Data Presented for Endotronix's Cordella PA Pressure Sensor System
November 18, 2019—Endotronix announced that data from the SIRONA first-in-human trial for the Cordella pulmonary artery (PA) pressure sensor system were presented by Prof. Dr. Wilfried Mullens at the 2019 American Heart Association (AHA) Scientific Sessions, held in Philadelphia, Pennsylvania, November 16–18, 2019.
The SIRONA trial studied 15 patients at two European sites: one hosted by Prof. Dr. Mullens at the Hospital Oost-Limburg in Genk, Belgium and the other by Faisal Sharif, MBBS, MRCPI, FESC, at the National University of Ireland in Galway, Ireland.
According to Endotronix, the 90-day results from the trial confirm the device safety and accuracy of pressure measurements in the right PA using the implanted Cordella Sensor and handheld patient reader. The primary accuracy endpoint was met with no significant difference in measured mean PA pressure for the Cordella Sensor and the reference catheter at 90 days.
Additionally, the study demonstrated encouraging safety results with no device-related system complications at 90 days, reported Endotronix. The company also noted high patient compliance (> 98%) with daily remote measurements of vital signs and PA pressure throughout the study.
“Chronic heart failure patients too frequently have cycles of decompensation and hospitalization that negatively impact patient outcomes and drive up treatment costs. Recent data show that using PA pressure-guided therapy with this population keeps them healthier and out of the hospital,” commented Prof. Dr. Mullen, in the company’s press release. “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.”
Endotronix described the Cordella Sensor as designed to seamlessly integrate PA pressure data into the Cordella System, which is used to provide a comprehensive health status of patients at home with easy-to-use tools to securely collect and share health-related data with health care providers for trend-based management. Together, both devices proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities, advised the company.
The Cordella Sensor is not available for commercial use in any geography, noted the company. The device is under clinical investigation in Europe (SIRONA II) and the United States (PROACTIVE-HF). The Cordella System, without the sensor, is available for commercial use in the United States and European Union.