Elekta’s Leksell Gamma Knife Icon Gains CE Mark

Elekta’s Leksell Gamma Knife Icon has won CE Mark approval, with University Hospital La Timone in Marseilles, France, being the first to install the device, the Swedish firm said Tuesday.

The system, which features online Adaptive DoseControl technology for precise dose delivery and frameless treatment capability, can target almost any part of the brain, the company says. Patients can also decide whether to have treatments performed in single or multiple sessions.

Jean Régis, La Timone’s Gamma Knife program director, says the next step is to expand the device’s indication to allow for hypofractionation. This would allow multiple treatment sessions to be performed more readily, enable treatment of lesions in more anatomical sites and account for shifts in the patient’s position so that dosage can be adapted accordingly.

The hospital will treat the first patients using the system next month. FDA 510(k) clearance for the device is pending. — Jason Scott