The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease.

“Reaching IDE approval takes a lot of people believing in this work, and I’m grateful to every employee, physician, and partner who helped us get here,” FastWave Medical COO Tristan Tieso said. “We’re looking forward to demonstrating the capabilities of Artero in a rigorous IDE trial, and ultimately bringing an advanced IVL platform to the patients who need it most.”