Company plans Early Feasibility Study in the US for late 2023
PARIS, FRANCE / ACCESSWIRE / 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 today the successful first patient enrollment in its first-in-human clinical study.
The procedure was performed at the Israeli-Georgian Medical Center Helsicore in Tbilisi, Georgia, by Dr. Irakli Gogorishvili, Head of Interventional Cardiology at Helsicore and Dr. Alex Rothman, Senior Clinical Research Fellow at the University of Sheffield in the United Kingdom.
"Gradient has made significant progress over the past few years over the past few years," said Dr. Rothman. "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."
"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," said Dr. Gogorishvili. "We are actively screening for additional patients and look forward to working with our study collaborators to finish enrollment in this trial."
Between a third and half of heart failure patients around the world have elevated pulmonary vascular resistance, a combination that is shown to lead to an increased risk of mortality and hospitalization. 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.
"I'm proud of the hard-working team at Gradient who have gotten us to this significant milestone," said Martin Grasse, CEO of Gradient. "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 IDE Early Feasibility Study in the United States later this year.
About Gradient Denervation Technologies
Gradient Denervation Technologies has developed a minimally invasive device for the treatment of pulmonary hypertension in patients with heart failure. Gradient leverages intellectual property developed at Stanford University and has been incubated since 2020 by Sofinnova MD Start, a Paris-based medtech accelerator that actively works with clinicians and entrepreneurs to develop disruptive medical devices. The Gradient device is for investigational use only and is not approved for commercial use.
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SOURCE: Gradient Denervation Technologies