Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial
- The PROACTIVE-HF 2 trial is designed to expand access to NYHA class II patients and to scale pulmonary artery pressure-guided therapy with the Cordella Sensor
- In addition, the Company presented positive 12-month clinical data on a subset of patients in its pivotal PROACTIVE-HF clinical trial at the annual Heart Failure Society of America (HFSA) conference
NAPERVILLE, Ill., Oct. 9, 2023 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. The prospective, dual-arm trial aims to expand access to New York Heart Association (NYHA) class II HF patients and support efficient and scalable remote patient management with a clinician-directed, patient self-management strategy.
