FDA Clears AngioDynamics' Solero Microwave Tissue Ablation System
June 7, 2017—AngioDynamics announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Solero microwave tissue ablation (MTA) system. The Solero MTA system and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA system is not intended for cardiac use, advised the company.
According to AngioDynamics, the Solero MTA system features the Solero microwave (MW) generator and the specially designed Solero MW applicators. The solid-state Solero MW generator, with a 2.45 GHz operating frequency, can power up to 140 W for optimized power delivery and fast ablations. The Solero MW applicator's ceramic tip diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect nontargeted tissue ablation. In addition, the Solero MTA system has scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage, noted the company.