Elekta announced today that it received FDA 510(k) clearance to expand indications for its Leksell Gamma Knife radiosurgery system.
The system’s cleared indications now include refractory, intractable mesial temporal lobe epilepsy (MTLE) in adults. Gamma Knife surgery treats refractory, drug-resistant MTLE by precisely focusing 192 beams of gamma radiation to target and disrupt the exact region of the brain responsible for epileptic seizures. It potentially reduces frequency or eliminates the seizures without opening the skull.
Elekta designed its dedicated intracranial system designed exclusively for brain radiosurgery. Initially, the company focused on treating functional indications like intractable epilepsy without open brain surgery. Over the years, the company has brought it to a range of functional indications. Those include essential tremor, trigeminal neuralgia and intractable epilepsy.
The company says it offers nearly 2 million patients a non-invasive alternative that spares healthy brain tissue and critical structures.
“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, SVP 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.”
