FDA clears Covidien microwave ablation system

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The FDA has issued a 510(k) marketing clearance for Covidien’s Evident Microwave (MW) ablation system, intended for use in the ablation of nonresectable liver tumors.

The Hamilton, Bermuda-based Covidien said the Evident MW ablation system is for the coagulation of soft tissue during percutaneous, laparoscopic and open surgical procedures. The system uses microwave energy, emanating from the feed point of the radiating section of an antenna, to cause coagulation of the tissue. The microwave energy creates heat by generating friction through the vibration of water molecules. With microwave ablation, there is no current flow through the patient, eliminating the need for grounding pads.

The company said its new system offers a procedural option for patients who are not candidates for surgical resection and have few remaining treatment options.