July 18, 2008 - Misonix Inc. said it received 510(k) clearance from the FDA to market its Sonatherm 600i High Intensity Focused Ultrasound (“HIFU”) Soft Tissue Ablation System in the U.S., which will be used to ablate certain soft tissue lesions, excluding the prostate gland, in general surgery.
The Sonatherm 600i System is an evolution of the company’s Sonatherm 600 System that received FDA clearance in 2006. The Sonatherm 600i System adds imagery and motion capability. To date, the two Sonatherm Systems are the only HIFU-based soft tissue ablation systems that have received FDA clearance for general surgery, according to the company.
The Sonatherm 600i utilizes HIFU to ablate tissue intra-operatively or laparoscopically from a focal point back to the surface of the tissue of the lesion, eliminating the need to puncture or otherwise invade the tissue mass. This capability differentiates the Sonatherm from other conventional surgical devices; i.e. cryo or radio frequency, which generally requires the tissue mass, or organ, to be punctured with multiple needles or probes, said the company.
For more information: www.misonix.com