FDA Clears Enhanced MRI-Guided Laser Ablation System

The Food and Drug Administration has granted 510(k) clearance for the Visualase V2 MRI-Guided Laser Ablation System, a minimally invasive alternative for performing soft tissue ablation in patients with radiation necrosis, focal epilepsy, or brain tumors.

Through a small 4 mm incision, physicians can utilize the Visualase V2 system for targeted delivery of laser interstitial thermal therapy, which facilitates soft tissue ablation with MRI guidance in neurosurgical procedures, according to Medtronic, the manufacturer of the Visualase V2 system.

Offering enhanced precision and visualization, Medtronic said the Visualase V2 system features updated software and hardware to foster improved workflow efficiencies.

“This clearance is a significant advancement for patients and clinicians alike,” said Ashwini Sharan, M.D., the chief medical officer of Medtronic Neuromodulation. “By providing a minimally invasive option with real-time MRI guidance, we're enhancing surgical precision. This is an important advancement for neurosurgical procedures.”