Gradient Begins PreVail-PH2 Early Feasibility Study of Pulmonary Artery Denervation System

March 6, 2024—Gradient Denervation Technologies announced approval by the FDA to initiate the PreVail-PH2 early feasibility study in the United States. The first patient in the study was enrolled at Duke University Hospital in Durham, North Carolina.

The Paris, France-based company is developing a minimally invasive, ultrasound-based device designed to treat pulmonary hypertension patients with associated heart failure.

The PreVail-PH2 study is enrolling patients with pulmonary hypertension caused by left-sided heart disease, classified by the World Health Organization as Group 2 Pulmonary Hypertension. The company stated that there are no approved drug or device therapies for this group of pulmonary hypertension patients.

According to the company, the procedure under investigation uses the Gradient denervation system to ablate nerves around the pulmonary artery using therapeutic ultrasound energy.

This approach is intended to down-regulate the sympathetic nervous system’s input into the pulmonary vascular tree to reduce vascular resistance and lower pulmonary pressures. The Gradient device may provide a treatment option for patients with this condition on a platform designed for the pulmonary artery anatomy using known interventional techniques, noted the company.

The study’s first patient was enrolled by Marat Fudim, MD, Advanced Heart Failure Specialist, Duke Cardiology Center, and Richard Krasuski, MD, Adult Congenital Heart Failure Specialist and Director of the Adult Congenital Heart Center, Duke University Medical Center.

“We are excited to enroll the first United States patient in this important study,” commented Dr. Fudim in the company’s press release. “Completion of this study is a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.”

Dr. Krasuski added, “New technologies are needed to treat patients with pulmonary hypertension. We are actively screening for additional patients and will continue to work closely with our study collaborators to complete enrollment in this important trial.”

The Gradient device is for investigational use only and is not approved for commercial use, advised the company.

In June 2023, the company announced the initial patient enrollment in the first-in-human clinical study of its pulmonary artery denervation technology. That procedure was performed at the Israeli-Georgian Medical Center Helsicore in Tbilisi, Georgia.