Soft Tissue Ablation System Cleared
A new ultrasound system that ablates soft tissue received marketing approval from the Food and Drug Administration. The Sonatherm 600i High Intensity Focused Ultrasound (HIFU) Soft Tissue Ablation System is manufactured by Misonix, Incorporated. This device is indicated to treat patients with soft tissue lesions.
The HIFU in the Sonatherm system allows ablation of soft tissues from a focal point back to the surface of the lesion. It can be used either laparoscopically or intra-operatively. This approach negates the need to puncture or otherwise access the lesion.
The approach used with HIFU to destroy tissue is different than conventional tools currently available. Those generally utilize either radio or cryo frequency and necessitate tissue puncture of the lesion with multiple probes or needles.
The new Sonatherm 600i is an updated iteration of the company’s previously released Sonatherm 600. That product was initially cleared for marketing in 2006. New components of the 600i include imagery and motion capabilities. These are the only two systems in the U.S. that have received marketing clearance for ablation in the general surgery setting.
Studies with the device are currently underway at the University of Austria under the guidance of a renowned expert in HIFU. Studies are planned for the U.S. as well.
Misonix develops laboratory equipment and devices for the delivery of therapeutic ultrasound. Ultrasound tools from the company are used for neurosurgery, wound debridement, laparoscopic surgery, and cosmetic surgery in addition to other applications.
July 21, 2008 Related topics: Product Approval & Certification, Imaging, Surgery