Solero Microwave Tissue Ablation (MTA) System has FDA 510(k) approval for the ablation of soft tissue during open procedures. -AngioDynamics
AngioDynamics , a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology/surgery, announced the 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.
p> 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 optimized ceramic tip diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue ablation. In addition, the Solero MTA System offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage. .
Comment: AngioDynamics had received CE Mark certification in March 2017 for the Solero Microwave Tissue Ablation (MTA) System. The Solero MTA System and Accessories are indicated for the ablation of soft tissue during open, laparoscopic or percutaneous procedures.