Novel Acoustic Coupling Fluid Earns FDA Breakthrough Status for Enhanced Neurosurgical Imaging
The SonoClear System revolutionizes neurosurgery with FDA breakthrough designation, enhancing ultrasound imaging for safer tumor resections in glioma surgeries.
US FDA
- The SonoClear System, a novel acoustic coupling fluid, received FDA breakthrough device designation for significantly improving intraoperative ultrasound imaging during neurosurgical procedures, especially for aggressive neurological tumors like gliomas.
- This acoustic coupling fluid enhances neurosurgeons' ability to achieve maximal safe tumor resection by eliminating acoustic artifacts caused by conventional irrigation fluids, allowing for clearer visualization of tumor margins.
- The FDA's breakthrough designation for the SonoClear System indicates its potential to provide a more effective diagnosis for life-threatening conditions and will expedite its development and review, signaling a significant impact on neuro-oncology patient care.
The FDA Center for Devices and Radiological Health has granted breakthrough device designation to the SonoClear System, a novel acoustic coupling fluid and sterile transfer kit designed to significantly improve intraoperative ultrasound (ioUS) imaging during intracranial procedures.1
The acoustic coupling fluid is engineered to overcome a persistent limitation of conventional ioUS, where standard irrigation fluids like saline (0.9%) and lactated Ringer's solution create acoustic artifacts. These artifacts often obscure critical tumor margins and residual disease at the base of a resection cavity, hindering the neurosurgeon's ability to achieve maximal safe resection. By mimicking the acoustic properties of brain tissue, the acoustic coupling fluid aims to eliminate these visual interferences, offering a high-definition, real-time image of the surgical site.
This designation from the FDA underscores the potential of the acoustic coupling fluid to address a critical unmet need in neurosurgical oncology by providing clearer visualization of tumor remnants, particularly in aggressive neurological tumors like gliomas.
"Removing aggressive neurological tumors, such as gliomas, presents a significant surgical challenge," stated Professor Geirmund Unsgaard, a neurosurgeon and founder of SonoClear AS, the company behind the acoustic coupling fluid. "Neurosurgeons rely on intraoperative ultrasound to guide their work and confirm complete tumor removal. Standard irrigation fluids create visual artifacts that can obscure the surgical site precisely when clarity is most critical: at the end of the procedure when surgeons need to verify whether any tumor remains. We created a simple solution that works with all intraoperative ultrasound systems and allows neurosurgeons to clearly see the tumor, enabling improved decision-making in surgery."
The ability to achieve a greater extent of resection in brain tumor surgery, particularly for gliomas, is directly correlated with improved patient outcomes, including overall survival and delayed tumor recurrence. However, the inherent challenges of tumor delineation and the limitations of current imaging modalities often impede this goal.
Intraoperative ultrasound is a widely available and cost-effective real-time imaging tool, but its diagnostic accuracy has historically been compromised by suboptimal imaging conditions. The acoustic coupling fluid addresses this by providing an acoustically optimized medium within the surgical cavity, allowing for enhanced differentiation between healthy tissue and tumor.
Tumor in brain: © peterschreiber.media - stock.adobe.com
Professor Francesco DiMeco, a neurosurgical specialist and renowned ioUS expert at the Neurological Institute Carlo Besta in Italy, and a principal investigator in studies of the acoustic coupling fluid, attested to its clinical utility. "Toward the end of a resection, with the acoustic coupling 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 acoustic coupling fluid."
The FDA's breakthrough device designation is reserved for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.2 This designation facilitates expedited development and review, signaling the FDA's recognition of the acoustic coupling fluid's potential to significantly impact patient care in neuro-oncology.
