AngioDynamics (NSDQ:ANGO) said today it won FDA 510(k) clearance for its Solero microwave tissue ablation system, with indications for the ablation of soft tissue during open procedures.
The company’s Solero MTA system features a Solero MW generator with a 2.45 GH operating frequency and specially designed Solero MW applicator.
The generator can power up to 140 W for faster ablation procedures, the company said, while the applicator’s ceramic tip diffuses MW energy near spherically with a cooling channel and thermocouple for real-time monitoring and to protect non-targeted tissue.
“The U.S. market has been asking AngioDynamics for a solid state, simple, fast, portable and scalable single applicator microwave system. 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,” oncology and surgery division GM Rick Stark said in a prepared statement.
In March, AngioDynamics said it won CE Mark approval in the European Union for its Solero microwave tissue ablation system.