Elekta has announced that its Leksell Gamma Knife® radiosurgery system has received FDA 510(k) clearance for an expanded indication: the treatment of refractory, intractable mesial temporal lobe epilepsy (MTLE) in adults.
This regulatory milestone allows U.S. providers to use the non-invasive Gamma Knife technology to precisely target the area of the brain responsible for epileptic seizures. The system utilizes 192 focused beams of gamma radiation, delivering high precision without the need for open brain surgery. This approach offers the potential to reduce—or even eliminate—seizure frequency in drug-resistant epilepsy patients while sparing healthy brain tissue.
Initially developed for intracranial radiosurgery, the Leksell Gamma Knife has evolved over time to treat a wide range of functional brain disorders, including essential tremor, trigeminal neuralgia, and intractable epilepsy. Nearly 2 million patients have benefited from this minimally invasive solution globally.
“For years, our clinical partners have used Gamma Knife to treat epilepsy with exceptional outcomes,” said Caroline Leksell Cooke, SVP and Head of Neuro Solutions at Elekta. “This new FDA clearance enables U.S. physicians to offer patients a non-invasive, precision therapy that improves outcomes and supports more efficient use of healthcare resources.”
With this approval, Elekta reinforces its commitment to advancing non-invasive neurosurgical options that preserve quality of life while expanding access to cutting-edge therapies.