How Recor Medical won the renal denervation race for FDA approval

The Recor Medical Paradise ultrasound RDN system uses a water-filled balloon catheter for 360-degree sonification to ablate overactive nerves in the walls of the renal arteries. [Illustration courtesy of Recor Medical]

It’s been a long wait to see the FDA approve renal denervation for treating hypertension.

Recor Medical held a companywide town hall for employees to celebrate winning premarket approval (PMA) for their Paradise Ultrasound RDN system. While they were celebrating, the team learned that the very first commercial procedure had just been completed.

“After a pretty long journey of many years — the rigorous clinical trials that we ran, and all the work that they’ve done —  they were actually seeing, finally, this wonderful result of a PMA,” Recor President and CEO Lara Barghout said. “We hit the ground running immediately. … It was such an incredible, emotiona…

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