Picking up where Gamma Knife Perfexion left off, the sixth generation of Elekta's stereotactic radiosurgical platform has received 510(k) approval from the FDA.
Like other Gamma Knife systems, the Icon is capable of ultra-precise dose delivery to lesions in the brain. Unlike previous Gamma Knife systems, however, the company says Icon represents a push toward frameless radiosurgery.
This frameless option enables Icon to treat a wider variety of tumor types and sizes. It also opens up the option of performing fractionated or hypofractioned treatments, retreatment and microradiosurgery — capabilities traditionally associated with devices less concentrated on brain treatments.
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According to a statement by Bill Yaeger, Elekta's executive vice president, regional North America, microradiosurgery is an ultra-precise form of treatment which Icon is the only system on the market capable of performing.
The Gamma Knife's headframe has traditionally been a crucial component to the highly specific dosimetry and radiation fall-off that makes the system so effective in treating small targets in the brain. The option of performing certain procedures without it will be welcome news for clinicians and patients alike.
The Gamma Knife – first developed back in the sixties and since used to treat almost 900,000 people with cranial radiosurgery – contains 192 cobalt-60 sources in a circular array that focus gamma radiation precisely onto a target.
The system was first unveiled in April at the 3rd ESTRO Forum in Barcelona, Spain. A brief video of the unveiling — and reactions from the crowd — can be seen here:
The Icon received CE Mark in June, and France's University Hospital La Timone has been the first to install an Icon in their facility. They were also the first hospital to install the previous generation Gamma Knife, the Perfexion, in 2006. Dr. Jean Regis, a neurosurgeon and program director for the hospital's Gamma Knife program, said there are two "significant opportunities" related to frameless immobilization on the Icon system.
The first, he said, will be able to enlarge the scope of indications by more readily permitting hypofractionation. More important, according to Regis, is the ability to evaluate shifts in the patient's position and to adapt the dose proactively to account for movement.
"This, in particular, will push frameless, hypofractionated radiosurgery to a level that doesn't exist today," said Regis.
At present it does not appear that any U.S. hospitals have purchased the Gamma Knife Icon.
