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FDA Clearance for The Solero Microwave Tissue Ablation System Announces AngioDynamics

AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology/surgery, today announced the U.S. 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.

“The U.S. market has been asking AngioDynamics for a solid state, simple, fast, portable and scalable single applicator microwave system,” said Rick Stark, Senior Vice President and General Manager of the Oncology/Surgery division of AngioDynamics. “The launch of the Solero in the U.S. will fulfill our commitment to physicians and provide them the innovative tools they have been asking for in the ablation of soft tissue.”

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.

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