Gradient Denervation Technologies announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP).
TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. The company expects its acceptance into the program to help accelerate its novel technology for treating pulmonary hypertension and associated heart failure. Acceptance also comes a month after the FDA granted the company breakthrough device designation.
Paris-based Gradient designed its technology to ablate nerves around the pulmonary artery. It uses therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform specifically targets the pulmonary artery anatomy, leveraging known interventional techniques. It aims to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures.
Gradient closed a $15 million Series A to support its catheter-based technology last September. The FDA gave the green light to begin an early feasibility study in March 2024.
“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, CEO at Gradient. “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.”
Renal denervation for treating hypertension continues to pick up steam. Medtronic and ReCor Medical both won major approvals last year. Earlier this year, Boston Scientific entered the denervation space with its acquisition of SoniVie.
