Gradient Denervation Technologies announced today that it received FDA breakthrough device designation for its denervation system.
Paris-based Gradient designed the novel technology to treat patients with pulmonary hypertension and associated heart failure. It ablates nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure.
Gradient closed a $15 million Series A to support its catheter-based technology last September.
The company said it designed its straightforward catheter platform specifically for 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 said it has enrollment underway in its PreVail-PH2 early feasibility study. The study includes patients with pulmonary hypertension due to left-sided heart disease. The FDA gave the green light to begin the early feasibility study in March 2024.
“We are thrilled with this positive feedback from FDA. The granting of breakthrough device designation marks another important milestone for our pulmonary denervation clinical development program,” said Martin Grasse, CEO of Gradient. “We remain focused on completion of our early feasibility study as a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.”
Renal denervation has gained a great deal of attention in the hypertension treatment space in recent years, with Medtronic and ReCor Medical both winning major approvals last year. However, those approvals enabled an adjunctive treatment option when lifestyle changes and medications fail to adequately control a hypertension patient’s blood pressure.
Earlier this month, Boston Scientific also entered the denervation space with its acquisition of SoniVie.
