Medical technology company Endotronix Inc reported on Thursday the receipt of conditional Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence the multi-centre PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) in chronic heart failure patients.

With the launch of the trial in the third quarter of 2019, the company plans to expedite Pre-Market Approval (PMA) of the Cordella Sensor and provide evidence to inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).

PROACTIVE-HF is a prospective, multi-centre, randomised, controlled trial that will evaluate the safety and efficacy of the Cordella Sensor in over 950 patients at up to 60 sites across the US.

The primary endpoints will assess device safety in addition to the rate of mortality and HF hospitalisation or use of IV diuretics at 12 months. Key secondary endpoints of the trial include change in PA pressure, HF medication changes, device performance and patient quality of life.

According to the company, the Cordella Sensor is fully integrated with the Cordella Heart Failure System (Cordella System), which provides a comprehensive health status of the patient at home with a remote patient management platform and easy-to-use tools to securely collect and share daily patient data with healthcare providers. The Cordella System is available for commercial use in the U.S. and E.U. and is currently in cardiology centres across the U.S.