Gradient’s Pulmonary Artery Denervation System Receives FDA Breakthrough Designation

May 19, 2025—Gradient Denervation Technologies, which is based in Paris, France, announced that the company’s pulmonary artery denervation (PADN) system has received FDA Breakthrough Device designation.

The designation allows for 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, noted the company.

According to the company, the Gradient denervation system is intended to treat patients with pulmonary hypertension and associated heart failure. The device uses therapeutic ultrasound energy in a percutaneous procedure to ablate nerves around the pulmonary artery. The treatment aims to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures.

Gradient advised that the PreVail-PH2 early feasibility study is enrolling patients with pulmonary hypertension caused by left-sided heart disease, classified by the World Health Organization as Group 2 Pulmonary Hypertension. There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients, noted the company.

In March 2024, Gradient announced FDA approval to initiate the PreVail-PH2 study in the United States.

The Gradient denervation system, which leverages intellectual property developed at Stanford University in Stanford, California, is available for investigational use only and is not approved for commercial use, advised the company.