Gradient Denervation Technologies Announces Acceptance into FDA's Total Product Life Cycle Advisory Program for Development of its Pulmonary Artery Denervation System
PARIS, June 18, 2025 (GLOBE NEWSWIRE) -- Gradient Denervation Technologies announced today that it has been accepted into the Total Product Life Cycle Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel technology intended to treat patients with pulmonary hypertension and associated heart failure. The TAP Pilot acceptance follows the Company's recent announcement that the FDA granted Breakthrough Device Designation for the Gradient Denervation System.
The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite patient access to safe and effective, innovative medical devices. To help accelerate development of Gradient's Denervation System, the TAP Pilot will allow the company to have early and frequent interactions with FDA as well as obtain strategic advice from providers, associations, payors and patient organizations.
The Gradient Denervation System is a novel technology intended to treat patients with Group 2 pulmonary hypertension due to left-sided heart disease. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures.
'We're excited to be included in the TAP Pilot as the program will help streamline collaboration with FDA – from initiating our pivotal clinical study to accelerating access to this breakthrough therapy upon approval,' said Martin Grasse, Chief Executive Officer at Gradient Denervation Technologies. 'There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients, which reinforces the need to expedite access to new innovative therapies. We expect that guidance from TAP Pilot advisors will be immensely valuable in developing a targeted therapy intended to improve outcomes and quality of life for these underserved patients.'
About Gradient Denervation Technologies
Gradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension. Gradient leverages intellectual property developed at Stanford University. The Gradient Denervation System 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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