FDA grants IDE approval for expanded study of PA sensor

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On Oct. 9, 2023, the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to Endotronix’s Cordella sensor for pulmonary artery (PA) pressure-guided therapy. This action allows the company to expand its PROACTIVE-HF 2 prospective, dual-arm study. 

The open label, randomized, controlled clinical trial will include up to 1,500 patients in the United States and Europe. It will evaluate the safety and efficacy of PA pressure-guided therapy using the Cordella sensor in New York Heart Association (NYHA) class II patients who have heart failure (HF) and are at risk for congestion. Endotronix expects to begin enrolling patients in late 2023.

The company’s second, expanded study will measure efficacy and safety using a compositive first HF event or death rate for up to 24 months. In addition, the study’s single-arm cohort will assess the impact of clinician-directed, patient-managed, at-home therapy in NYHA class III HF patients who are at risk for poor outcomes. Both arms will collect data on secondary endpoints, including changes in right ventricular function in relation to PA pressure, as well as patient management.

Clinicians, along with patients in both cohorts of the study, will have daily access to telehealth data, such as weight, heart rate and blood pressure. The treatment cohort also will have daily access to PA pressure data. 

Previously, Endotronix studied NYHA class III patients in its initial PROACTIVE-HF trial. The 12-month sub study data demonstrated a low HF hospitalization rate of 0.34 within the population. Other findings include:

·      78% of patients made lifestyle changes based on their mean PA pressure (mPAP) trends

·      86% of patients rated a positive impact of PA pressure management on their health

The company is preparing its PROACTIVE-HF study data for pre-market approval submission to the FDA by the end of 2023 and will present its complete findings in early 2024. 

“The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years,” said Lynne W. Stevenson, global principal investigator of the PROACTIVE-HF 2 clinical trial. “The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm. The single-arm cohort evaluates the power of engaged patients and subsequent impact on outcomes. Together, these studies help us better understand the impact of pulmonary hypertension on right ventricular function over time and provide guidance on how to scale this important therapy with patient engagement.”

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