May 19, 2025 — Gradient Denervation Technologies recently announced the company’s pulmonary denervation system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This program creates an expedited review pathway for devices that have the potential to provide more effective treatment for life-threatening or debilitating conditions and meet FDA’s rigorous standards for safety and efficacy.
The Gradient Denervation System is a novel technology intended to treat patients with pulmonary hypertension and associated heart failure. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures.
The PreVail-PH2 Early Feasibility Study is enrolling patients with pulmonary hypertension due to left-sided heart disease, classified by the World Health Organization (WHO) as Group 2 Pulmonary Hypertension. As many as two-thirds of heart failure patients around the world have elevated pulmonary vascular resistance, which is shown to lead to an increased risk of mortality and hospitalization. There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients.
“We are thrilled with this positive feedback from FDA. The granting of Breakthrough Device Designation marks another important milestone for our pulmonary denervation clinical development program,” said Martin Grasse, Chief Executive Officer of Gradient. “We remain focused on completion of our early feasibility study as a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.”
Gradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension.
For more information, please visit: www.gradientdenervation.com.
June 12, 2025 
