Gradient Begins First-In-Human Study of Pulmonary Artery Denervation Technology

June 1, 2023—Gradient Denervation Technologies, a Paris-based medical device company developing a minimally invasive device for treating certain heart failure patients with associated pulmonary hypertension, announced the initial patient enrollment in its first-in-human clinical study of the company’s pulmonary artery denervation technology. Additionally, the company advised it intends to begin an early feasibility study of the technology in the United States in 2023.

According to the company, the Gradient device works to “down-regulate” the sympathetic nervous system’s input into the pulmonary vascular tree to reduce vascular resistance and provide a treatment option for patients with this debilitating condition. The Gradient device is for investigational use only and is not approved for commercial use, noted the company.

The first-in-human study procedure was performed at the Israeli-Georgian Medical Center Helsicore in Tbilisi, Georgia, by Irakli Gogorishvili, MD, and Alex Rothman, BM BCh, PhD. Dr. Gogorishvili is Head of Interventional Cardiology at Helsicore, and Dr. Rothman is Senior Clinical Research Fellow at the University of Sheffield in the United Kingdom.

“Gradient has made significant progress over the past few years,” commented Dr. Rothman in the company’s press release. “With no approved drug or device therapies for this group of pulmonary hypertension patients, the technology is poised to have a huge impact on patient care.”

Dr. Gogorishvili added, “My team at Helsicore is happy to be working with Gradient to bring this therapy to patients for the first time in the world at our center. We are actively screening for additional patients and look forward to working with our study collaborators to finish enrollment in this trial.”

Also in the company’s press release, Gradient’s CEO Martin Grasse stated, “I’m proud of the hard-working team at Gradient who have gotten us to this significant milestone. We are one step closer to bringing this important therapy to patients. In conjunction with our first-in-human study in Georgia, we will be working with the FDA to get approval for, then initiate, an investigational device exemption early feasibility study in the United States later this year.”