
Endotronix Announces New IDE for Class II Heart Failure Patients and Positive Early Data in PROACTIVE-HF Study for Class III Patients
Endotronix, a prominent digital health and medical technology firm specializing in heart failure treatment, has received FDA approval for its Investigational Device Exemption (IDE) to conduct a multicenter study called PROACTIVE-HF 2. This study will assess the Cordella Sensor’s effectiveness in guiding pulmonary artery (PA) pressure-based therapy. It targets New York Heart Association (NYHA) class II heart failure patients and aims to enhance remote patient management with a clinician-directed, patient self-management approach.
PROACTIVE-HF 2 is a prospective, open-label randomized controlled clinical trial set to enroll up to 1,500 patients across the U.S. and Europe. It will evaluate the safety and efficacy of PA pressure-guided therapy using Cordella in NYHA class II patients at risk of congestion. Both cohorts will have access to daily trended telehealth data, with the treatment group also receiving daily PA pressure data. The study will assess safety and efficacy through a composite measure of the first HF event or death rate over 24 months. The single-arm study will focus on clinician-directed patient self-management in NYHA class III HF patients, with a 12-month endpoint for safety and HF-related hospitalization or death. Secondary endpoints include changes in right ventricular function in relation to PA pressure and patient engagement.
The approval follows positive findings from a sub-study of the pivotal PROACTIVE-HF clinical trial in NYHA Class III patients presented at the Heart Failure Society of America annual meeting. In the unblinded period, average seated mean pulmonary artery pressure for patients above target (>20 mmHg) decreased significantly (28.1 mmHg vs. 23.6 mmHg, p=0.03). Additionally, the 12-month unblinded HF hospitalization rate was significantly lower than the 12 months prior to implant (0.3 ±0.9 vs. 1.3±0.9, p<0.0001). Furthermore 78% of patients made lifestyle changes based on their mPAP trends and 86% of patients rated a positive impact of PA pressure management on their health.
Endotronix plans to share the full results of the PROACTIVE-HF trial next year and announced in April that it had completed enrollment in the study. The company plans to submit data to the FDA for pre-market approval (PMA) by the end of this year, with data presentation slated for the first half of the next year. Harry Rowland, CEO and co-founder of Endotronix, expressed confidence in the Cordella system’s benefits and projected a mid-2024 product launch.
The Cordella pulmonary artery (PA) pressure sensor is an investigational, wireless, microelectromechanical system (MEMS) sensor that allows remote monitoring of PA pressures. It is surgically implanted in the left pulmonary artery. If approved by the FDA, it will compete against the CardioMEM’s HF sensor which is owned by Abbott, and is the only FDA approved heart failure sensor on the market today. Other companies such as Cardiosense are also developing non-surgical technologies for heart failure management.