SonoClear System Gets FDA Breakthrough Device Designation for Enhancing Ultrasound-Guided Brain Tumor Resection
The acoustic coupling fluid and sterile transfer kit reportedly removes acoustic artifacts that can occur with the use of standard irrigation fluids in ultrasound-guided neurosurgical interventions.
The Food and Drug Administration (FDA) has issued a breakthrough device designation for the SonoClear System, an acoustic coupling fluid and sterile transfer kit that improves the clarity of intraoperative ultrasound in brain tumor surgery.
In contrast to the use of standard irrigation fluids that commonly obscure tumor remnants at the base of a resection cavity, the
SonoClear maintained that the removal of acoustic artifacts with the SonoClear System enables improved confirmation of complete tumor removal with intraoperative ultrasound.
"Toward the end of a resection, with SonoClear fluid in the cavity, I could clearly see whether there was any tumor remnant, which is not always the case when we use standard irrigation fluids as a couplant. This gives me confidence that I can achieve a maximum safe resection using intraoperative ultrasound combined with the SonoClear System,” noted Francesco DiMeco, M.D., the director of neurological surgery at the Neurological Institute Carlo Besta in Milan, Italy, and professor neurosurgery in the Department of Oncology and Hemato-oncology at the University of Milan.
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