Radiation therapy firm RITA Medical Systems has received Food and Drug Administration 510(k) clearance for its MR-compatible RITA StarBurst XL, a radiofrequency ablation (RFA) device.
The new version allows placement of the electrosurgical device under MR image guidance. Although the company would not divulge the material composition of the MR-compatible version of StarBurst XL, FDA documents show it has a polymer handle.
According to the Mountain View, CA, vendor, the device has been cleared for use in percutaneous, laparoscopic, or open surgical procedures in coagulation and ablation of soft tissue. It is also used for the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.
RITA did not offer a price estimate, but said it expects to start shipping the product in the second quarter of this year.
By AuntMinnie.com staff writersJanuary 22, 2003
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