Gradient Denervation Technologies announced on May 19, 2025, that its pulmonary denervation system has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation establishes an expedited review pathway for the device, which shows promise in providing more effective treatment for life-threatening conditions while meeting the FDA's stringent safety and efficacy standards.
The Paris-based company's Gradient Denervation System represents a novel approach to treating patients suffering from pulmonary hypertension and associated heart failure. The technology works by ablating nerves surrounding the pulmonary artery using therapeutic ultrasound energy delivered through a minimally invasive, percutaneous procedure.
Novel Mechanism of Action for an Underserved Patient Population
The system's catheter platform was specifically engineered for pulmonary artery anatomy and builds upon established interventional techniques. Its primary therapeutic goal is to down-regulate sympathetic activity in the pulmonary vascular tree, thereby reducing vascular resistance and decreasing pulmonary pressures.
Currently, the company is conducting the PreVail-PH2 Early Feasibility Study, which is enrolling patients with pulmonary hypertension due to left-sided heart disease. This condition is classified by the World Health Organization (WHO) as Group 2 Pulmonary Hypertension.
The clinical significance of this development is substantial, as approximately two-thirds of heart failure patients globally have elevated pulmonary vascular resistance, a condition associated with increased mortality and hospitalization risk. Notably, there are currently no FDA-approved drug or device therapies in the United States specifically for this group of pulmonary hypertension patients.
Clinical Development Program Advances
Martin Grasse, Chief Executive Officer of Gradient, expressed enthusiasm about the FDA designation: "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."
Grasse emphasized the company's commitment to addressing this significant unmet medical need: "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."
Technology Background and Current Status
Gradient Denervation Technologies leverages intellectual property developed at Stanford University to create its minimally invasive, ultrasound-based device. The company notes that the Gradient Denervation System is currently for investigational use only and has not yet received approval for commercial use.
The Breakthrough Device Designation program is designed to accelerate the development and review of medical devices that offer more effective treatment for life-threatening or irreversibly debilitating conditions. For patients with Group 2 Pulmonary Hypertension, who currently lack targeted therapeutic options, this designation represents a potentially significant step toward addressing a critical gap in treatment availability.
