News | Radiation Therapy | June 03, 2016

Elekta’s Leksell Gamma Knife Icon Cleared for Use in Japan and United States

Patients and clinics to benefit from next-generation stereotactic radiosurgery system

Elekta, Leksell Gamma Knife Icon, Japan, United States, U.S. approval, radiosurgery system

June 3, 2016 — Elekta announced that its Leksell Gamma Knife Icon radiosurgery system has been cleared for clinical use by both the Japanese Ministry of Health, Labour and Welfare and the Nuclear Regulatory Commission in the United States.

Icon offers physicians increased flexibility for treatment of certain brain tumors, vascular malformations and functional disorders by allowing either frame-based or frameless methods to immobilize the patient’s head, while ensuring the highest level of precision. This allows patients with larger brain tumors and lesions close to critical brain structures to be treated with Gamma Knife accuracy and confidence.

Leksell Gamma Knife Icon received 510(k) approval from the U.S. Food and Drug Administration (FDA) in August 2015 and CE marking in June 2015. It has also been cleared by the MFDS for clinical use in The Republic of Korea.

The total number of cancer patients in Japan is estimated at about 980,000 a year, approximately 100,000 (10 percent) of whom will develop metastatic brain tumors. Only about 10,000 of these patients receive Gamma Knife treatment each year. Now, with Leksell Gamma Knife Icon, the number of patients who can receive stereotactic radiosurgery to the affected area would increase considerably.

Unique to Icon is the integrated stereotactic cone-beam CT (CBCT) 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.

For more information: www.elekta.com

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