Trod Medical: FDA 510(k) Clearance for Encage
Trod Medical has received FDA 510(k) clearance for Encage, a minimally invasive technology for soft tissue ablation. The surgical system allows for precise percutaneous ablation of target tissue with well-defined margins, helping spare healthy surrounding tissue.
Encage electrodes are inserted percutaneously and guided using ultrasound imaging. The electrode is viewed in real time via the ultrasound image while being precisely positioned into the target tissue. Encage may be used with a stand-alone, proprietary software for surgical planning and image guidance during the procedure. A RF-bipolar generator precisely controls the ablation.
The company expects to ship product for the initial human clinical trials in the first quarter of 2009. The device has potential applications in prostate, kidney and liver cancer treatment.
