FDA clears Leksell Gamma Knife Icon


Elekta’s Leksell Gamma Knife Icon radiosurgery system has received 510(k) clearance from the US Food and Drug Administration, enabling US healthcare providers to offer this advanced technology to their patients. With stereotactic imaging, online Adaptive DoseControl, ultra-precise dose delivery and the availability of frameless treatments, Icon is capable of treating virtually any target in the brain, regardless of type, location or volume.

Gamma Knife Icon represents the sixth generation of the company’s Leksell Gamma Knife system, a technology that has been in use worldwide and continually evolving since the 1980s. Gamma Knife radiosurgery is a gentler alternative to traditional brain surgery for illnesses such as metastatic disease, which is cancer that has travelled to the brain from elsewhere in the body. With pinpoint accuracy, the system delivers up to thousands of low-intensity radiation beams to one or more targets in a single session.

“Leksell Gamma Knife Icon offers a new model for the application of precise radiosurgery for a virtually unlimited range of cranial cases,” says Bill Yaeger, executive vice president Region North America. “Physicians have the flexibility to employ either frame-based or frameless techniques to immobilise the patient’s head, in addition to the option to treat the patient in one session or multiple sessions. Importantly, Icon is the only system with the accuracy to enable ultra-precise microradiosurgery in cases that demand the utmost precision.”

Integrated in Gamma Knife Icon are novel online Adaptive DoseControl and high-definition motion management technologies that assure the highest accuracy for all treatments, as well as an efficient workflow.

Soon after Elekta CE marked Gamma Knife Icon in June 2015, the University Hospital La Timone (Marseilles, France) installed the first Gamma Knife Icon system.