Elekta’s Gamma Knife Gains FDA Clearance to Treat Drug-Resistant Epilepsy

Elekta has received U.S. FDA 510(k) clearance to use its Leksell Gamma Knife radiosurgery system for treating adult patients with refractory, drug-resistant mesial temporal lobe epilepsy (MTLE). This non-invasive technique delivers 192 precisely targeted beams of gamma radiation to disrupt the seizure-generating brain region—offering an alternative to open brain surgery for patients unresponsive to medication.

Originally developed for functional brain disorders, the Gamma Knife has a long history of treating neurological conditions such as essential tremor, trigeminal neuralgia, and intractable epilepsy. With this expanded indication, U.S. neurosurgeons now have a validated option for managing complex epilepsy cases without compromising surrounding healthy tissue.

Elekta highlights the significance of this clearance in enhancing patient outcomes and care efficiency. The company notes that the technology has already been used off-label for epilepsy in select centers with promising results, and this FDA decision reinforces its broader clinical potential.