Gradient Denervation Technologies Enrolls First Patient in Early Feasibility Study of Pulmonary Artery Denervation System

2024-03-06

临床研究

FDA-Approved US study intended to evaluate pulmonary artery denervation in heart failure patients with WHO Group 2 Pulmonary Hypertension

PARIS, March 6, 2024 /PRNewswire/ -- Gradient Denervation Technologies, a Paris-based medical device company developing a minimally-invasive, ultrasound-based device designed to treat pulmonary hypertension patients with associated heart failure, announced today that the Food and Drug Administration (FDA) has approved the initiation of the PreVail-PH2 Early Feasibility Study in the United States. The company also announced the successful enrollment of the first patient in the study at Duke University Hospital, Durham, NC.

The PreVail-PH2 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 half 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 for this group of pulmonary hypertension patients.

The procedure under investigation uses the Gradient Denervation System to ablate nerves around the pulmonary artery using therapeutic ultrasound energy. This 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 debilitating condition on a platform designed for the pulmonary artery anatomy using known interventional techniques.

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," noted 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," said 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," says Martin Grasse, Gradient's CEO. "We look forward to continuing to work with the FDA and our clinical partners as we enroll this study."

About Gradient Denervation Technologies

Gradient Denervation Technologies is developing a minimally invasive device for the treatment of pulmonary hypertension in patients with heart failure. Gradient leverages intellectual property developed at Stanford University. The Gradient device is for investigational use only and is not approved for commercial use.

For more information, please visit: https://www.gradientdenervation.com.

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