FDA-Approved US study intended to evaluate pulmonary artery denervation in heart failure patients with WHO Group 2 Pulmonary Hypertension
PARIS, March 6, 2024 /PRNewswire/ — Gradient Denervation Technologies, a Paris-based medical device company developing a minimally-invasive, ultrasound-based device designed to treat pulmonary hypertension patients with associated heart failure, announced today that the Food and Drug Administration (FDA) has approved the initiation of the PreVail-PH2 Early Feasibility Study in the United States. The company also announced the successful enrollment of the first patient in the study at Duke University Hospital, Durham, NC.