Announcing 510 (k) Clearance For ENCAGE™
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10/27/2008
Trod Medical® Announces 510 (k) Clearance For ENCAGE™, their minimally Invasive Soft Tissue Ablation Device
Parrish, Florida, October 22nd, 2008 – Trod Medical US, LLC today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ENCAGE™ their patented, minimally invasive breakthrough technology for soft tissue ablation. This surgical system allows for precise percutaneous ablation of target tissue with well-defined margins, while leaving surrounding tissue unaffected in organs such as Prostate, Kidney and Liver.
We are excited at the prospect that our ENCAGE™ minimally invasive Bipolar RF Technology will have a positive patient impact with a “Confined, Controlled and Complete” tissue ablation in comparison to existing Ultrasound Image Guidance technologies currently available today
The company expects to ship product for the initial human clinical trials in the first quarter of 2009.They also plan to host clinical education programs for surgeons throughout all of 2009.
