Endotronix, Inc. announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi- center PROACTIVE-HF trial of the CordellaTM Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor).
The innovative trial is designed 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). The company plans to begin enrollment in the trial in the third quarter of 2019.
“We are excited to begin enrollment in this groundbreaking trial that will provide the highest level of clinical evidence to redefine the standard of care for patients suffering from chronic heart failure,” stated Katrin Leadley, MD, Chief Medical Officer of Endotronix. “The trial design and treatment guidelines aim to proactively lower patient PA pressures and enable physicians to maintain target pressures, which we believe will decrease patient mortality lower the rate of HF-related hospitalizations.”
PROACTIVE-HF is a prospective, multi-center, randomized, controlled trial that will evaluate the safety and efficacy of the Cordella Sensor in over 950 patients at up to 60 sites across the U.S. The trial will assess the benefits of PA pressure-guided management with the Cordella Sensor for New York Heart Association (NYHA) Class III heart failure patients. The primary endpoints will assess device safety in addition to the rate of mortality and HF hospitalization 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.
The Cordella Sensor is fully integrated with the CordellaTM 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. Together 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.
“This is a pivotal milestone for both the company and patients suffering from heart failure. PROACTIVE-HF is designed to show a definitive benefit for PA pressure-guided management and provide the data required for reimbursement of the implantable Cordella Sensor across the U.S.,” commented Harry Rowland, CEO of Endotronix. “This study along with our recently initiated CE Mark trial, SIRONA II, will build a solid clinical foundation for market adoption of the Cordella Sensor and Cordella System.”
The Cordella Sensor is an investigational device and is not available for commercial use in any geography. CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
The Cordella System is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.