FDA Approves IDE for PROACTIVE-HF Pivotal Trial of Endotronix's Cordella Pulmonary Artery Pressure Sensor System

August 1, 2019—Endotronix, Inc. announced that it has received conditional investigational device exemption approval from the FDA to begin the PROACTIVE-HF trial of the company's Cordella pulmonary artery pressure sensor system. Enrollment in the trial is planned to begin in the third quarter of 2019. The trial is designed to expedite premarket approval of the Cordella sensor and provide evidence to inform a national coverage decision from the Centers for Medicare & Medicaid Services.

PROACTIVE-HF is a prospective, multicenter, randomized controlled trial that will evaluate the safety and efficacy of the Cordella sensor in more than 950 patients at up to 60 sites across the United States. The trial will assess the benefits of pulmonary artery pressure–guided management with the Cordella sensor for New York Heart Association class III heart failure (HF) patients.

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

According to the company, the Cordella sensor is fully integrated with the Cordella HF 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 health care providers.

The Cordella system and sensor aim to proactively deliver the information necessary to improve patient care between office visits while supporting reimbursement for care delivery activities. The system was designed for remote titration of medication and streamlining patient management to help keep patients out of the hospital.

Endotronix advised that the Cordella sensor is an investigational device and is not available for commercial use in any geography. The Cordella system is available for commercial use in the United States and the European Union.

The company intends to use this study along with the recently initiated European CE Mark approval trial, SIRONA 2, to build a solid clinical foundation for market adoption of the Cordella sensor and Cordella system.