Amended study design provides immediate access and clinical benefits for all patients and becomes the first global IDE study for PA pressure-guided heart failure management
LISLE, Ill., Jan. 5, 2022 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor1, shifting the design from a randomized control study to a single-arm study. Following the 2021 update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment and the recently presented GUIDE-HF data, the FDA’s decision underscores the clinical benefits of PA pressure-guided HF management for New York Heart Association (NYHA) class III heart failure patients2,3. The new PROACTIVE-HF trial design ensures the over 100 previously enrolled patients have immediate access to the proven clinical benefits of PA pressure-guided therapy and expands the study to include clinical sites across Europe, as well as the U.S. The company is currently implementing the updated PROACTIVE-HF study design at trial sites worldwide.
