Elekta’s Leksell Gamma Knife Icon has been cleared for clinical use by both the Japanese Ministry of Health, Labour and Welfare and the Nuclear Regulatory Commission in the USA.
According to a company release, Icon is designed to offer physicians increased flexibility by allowing either frame-based or frameless methods to immobilise the patient’s head, while ensuring the highest level of precision.
Leksell Gamma Knife Icon received 510(k) approval from the US Food and Drug Administration in August 2015 and CE marking in June 2015. It has also been cleared by the MFDS for clinical use in South Korea.
According to the release, Icon offers the only integrated stereotactic cone-beam computed tomography imaging technology that can check the patient’s position against the treatment plan and automatically recalculate the plan to correct for movement, thus ensuring the highest precision. During treatment, Icon’s novel HD motion management system manages patient movement by using infrared marker tracking to monitor cranial position.