The Ablatherm device, like SonaCare’s Sonablate 450, is designed to ablate prostate tissue using high-intensity focused ultrasound. After a years-long dance with the FDA that saw it move from a pre-market approval application to a de novo bid, Edap applied for 510(k) clearance after the agency cleared the Sonablate 450 in October.
Today the Lyon, France-based company said it expects to begin marketing the device in the U.S. immediately.
“This is a tremendous achievement for the company and the result of many years of hard work from our team. This clearance represents a unique opportunity for Edap and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe. With an established U.S. sales and services infrastructure, the pieces are in place to begin deploying Ablatherm devices in the U.S. very quickly and we look forward to bringing the technology to urologists as well as patients in need,” CEO Marc Oczachowski said in prepared remarks.