Gradient Starts U.S. Pulmonary Artery Denervation Trial

Gradient Denervation Technologies has received U.S. Food and Drug Administration (FDA) approval to begin its PreVail-PH2 early feasibility study in the U.S. The first patient was enrolled in the study at Duke University Hospital in Durham, N.C.
 
The Paris-based company is developing a minimally invasive, ultrasound-based device to treat pulmonary hypertension with associated heart failure. The PreVail-PH2 study is enrolling patients with pulmonary hypertension due to left-sided heart disease, classified by the WHO as Group 2 Pulmonary Hypertension. There are currently no drug or device therapies approved for this group of pulmonary hypertension patients.
 
The Gradient Denervation system ablates nerves around the pulmonary artery using therapeutic ultrasound. This aims to down-regulate the sympathetic nervous system’s input into the pulmonary vascular tree to lower vascular resistance and pulmonary pressures.
 
The patient was enrolled by Marat Fudim, MD, MHS, 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 US patient in this important study,” said Dr. Fudim. “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.”  
 
“New technologies are needed to treat patients with pulmonary hypertension,” added Dr. Krasuski. “We are actively screening for additional patients and will continue to work closely with our study collaborators to complete enrollment in this important trial.”
 
“We are thrilled to initiate this study and bring our technology to patients in the United States,” said Martin Grasse, Gradient’s CEO.  “We look forward to continuing to work with the FDA and our clinical partners as we enroll this study.”
 
The company closed a €14 million Series A financing round to support clinical development and evaluation in November 2023.