Elekta AB said it received U.S. regulatory clearance for its Leksell Gamma Knife radiosurgery system to treat a form of drug-resistant epilepsy in adults.
The U.S. Food and Drug Administration's 510(k) clearance is for intractable mesial temporal lobe epilepsy, a condition where seizures cannot be controlled with medication, the company said.
The system treats the condition by focusing 192 beams of gamma radiation to target the brain region responsible for seizures, providing a non-invasive alternative to open surgery.
The approval comes as the Swedish medical-technology company undergoes a strategic overhaul, having appointed Jakob Just-Bomholt as its new chief executive last month.
In June, Elekta also announced a proactive order review resulting in a 4.9 billion Swedish kronor cancellation from its backlog, a move aimed at improving profitability and predictability.
“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.”
According to the company, the Gamma Knife system has been used globally since 1968 and has treated nearly two million patients for various brain conditions.
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