Gradient wins FDA breakthrough nod for pulmonary artery denervation tech

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.

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