Elekta’s Gamma Knife Radiosurgery System Wins FDA Nod for Drug-Resistant Epilepsy

Elekta has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for new indications on its Leksell Gamma Knife radiosurgery system. They include clearance for refractory, intractable mesial temporal lobe epilepsy (MTLE) in adults.

Gamma Knife treats this type of epilepsy by precisely focusing 192 beams of gamma radiation to target and disrupt the exact brain region responsible for epileptic seizures. The procedure can reduce frequency of seizures or eliminate them without opening the skull.

The dedicated intracranial system was designed exclusively for brain radiosurgery. It was developed by Swedish neurosurgeon Prof. Lars Leksell with the original purpose to treat functional indications like intractable epilepsy without needing open brain surgery. Since 1968, it’s been used worldwide to treat a range of functional indications including essential tremor, trigeminal neuralgia, and intractable epilepsy.

“For years, many of Elekta’s neuroscience clinical partners have used Gamma Knife to treat patients with epilepsy, often with remarkable outcomes,” said Caroline Leksell Cooke, Senior Vice President and Head of Neuro Solutions at Elekta. “With this new clearance, U.S. providers can now offer patients a non-invasive, precision treatment—an important step forward in improving patient outcomes while optimizing resource utilization.”

Last month, the company hired former 3Shape chief executive Jakob Just-Bomholt as its new chief executive officer.