Study to support U.S. FDA approval of the Cordella™ Pulmonary Artery Pressure Sensor System for the treatment of patients with chronic heart failure
Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) for the treatment of HF. The first two patients were successfully implanted with the Cordella Sensor by Drs. Navin Kapur and Michael Kiernan at Tufts Medical Center in Boston, Massachusetts and Dr. Liviu Klein at the University of California San Francisco (UCSF).
The prospective, multi-center, randomized, controlled, single-blind trial is expected to enroll over 950 New York Heart Association (NYHA) Class III heart failure patients at up to 60 sites across the U.S. The dual-arm trial design compares HF management using daily patient vital sign data versus daily vital sign plus PA pressure data. Designed to show a definitive benefit for PA pressure-guided management, the landmark trial incorporates protocolized PA pressure therapy guidelines and guideline-directed medical therapy (GDMT) for proactive HF management. Primary endpoints of the study include the reduction of HF hospitalizations and mortality. In addition, the data from this trial will support U.S. market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). The company also announced that last year they received Category B IDE Study approval from CMS, which will allow coverage of the Cordella Sensor and routine care services during the trial.
“Management of chronic heart failure patients can be challenging. The Cordella Sensor and System provide a unique combination of daily patient PA pressure and vital sign data, enabling me and my team to make smarter, trend-based clinical decisions before decompensation occurs,” commented Dr. Klein, Director of the Mechanical Circulatory Support Program at UCSF and National Principal Investigator of the PROACTIVE-HF trial. “Based on my early experience, the Cordella System offers an intuitive at-home patient experience, including a seated PA pressure reading, for remote management. I’m excited for the PROACTIVE-HF trial and look forward to clearly demonstrating the benefits of hemodynamic PA-pressure guided therapy and its impact on clinical outcomes.”
“PROACTIVE-HF is a groundbreaking trial, designed to provide the highest level of clinical evidence in support of PA pressure-guided therapy,” added Harry Rowland, Chief Executive Officer of Endotronix. “Our national coverage of top implanting centers positions us for successful study enrollment to further demonstrate that the Cordella Sensor and System provides efficient HF management, improves clinical outcomes and has the potential to redefine the standard of care for patients with chronic heart failure.”
The Cordella Sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial). CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for clinical investigations. The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.
About the Cordella™ Heart Failure System
The Cordella Heart Failure System (Cordella System) is designed to help patients suffering from chronic heart failure feel better and stay out of the hospital with streamlined care and remote medication titration. The system provides a comprehensive health status of the patient at home with easy-to-use tools that securely collect and share health data with healthcare providers for trend-based management. The Cordella Sensor seamlessly integrates pulmonary artery (PA) pressure data into the Cordella System. Together, they proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.
Endotronix, Inc., is a medical technology company focused on advancing the treatment of chronic heart failure. Privately held, the company is backed by world-class medtech investors including Aperture Venture Partners, BioVentures Investors, LSP, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and two unnamed corporate strategic investors. Learn more at www.endotronix.com.
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SPRIG Consulting LLC (847) 951-7430