FastWave Medical Gains FDA IDE Approval for Pivotal Trial of Artero™ Peripheral IVL System

FastWave Medical has received FDA Investigational Device Exemption (IDE) approval to begin a U.S. pivotal trial (SPARC trial) for its Artero™ electric intravascular lithotripsy (IVL) system. The trial will evaluate the safety and effectiveness of Artero™ in treating calcified peripheral lesions in up to 125 patients.