Leksell Gamma Knife Icon From Elekta Gains CE Mark

Elekta has won CE Mark approval for its Leksell Gamma Knife Icon precision radiosurgery system, with University Hospital La Timone in Marseilles, France, being the first to install the device.

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

“Leksell Gamma Knife Icon is a new concept for performing precision radiosurgery for all types of cranial cases with unlimited clinical and workflow flexibility,” said Tomas Puusepp, president/CEO of Elekta. “Clinicians can choose either frame-based or frameless methods to immobilize the patient’s head, as well as the option to perform the treatment in a single session or in multiple sessions. Icon is also based on available technology that can perform ultra-precise microradiosurgery for the cases where this is required.”

Professor Jean Régis, M.D., a neurosurgeon and program director for University Hospital La Timone’s Gamma Knife program, said the Icon presents doctors with two significant opportunities related to the ability to use frameless immobilization.

“The first will be to enlarge the scope of indications by permitting hypofractionation [multiple treatment sessions] to be performed more readily, and also treatment of lesions in additional anatomical sites. This is by virtue of the capability to perform frameless treatments with much better technical control,” he noted in a news release. “The second opportunity is the ability to evaluate shifts in the patient’s position and to adapt the dose proactively to account for these movements. This in particular, will push frameless, hypofractionated radiosurgery to a level that doesn’t exist today.”

The company has submitted the Leksell Gamma Knife Icon to the U.S. Food and Drug Administration for approval.

University Hospital La Timone doctors have used the Icon’s predecessor, Leksell Gamma Knife Perfexion, having been the world’s first hospital to treat patients with the system in 2006. In 2010, the hospital used its Perfexion to deliver radiosurgery to the center’s 10,000th patient. University Hospital La Timone’s Gamma Knife program is 23 years old and has employed four different versions of Leksell Gamma Knife, according to the company.

Based in Stockholm, Sweden, Elekta develops state-of-the-art tools and treatment planning systems for radiation therapy, including brachytherapy and radiosurgery, as well as workflow enhancing software systems across the spectrum of cancer care.