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
TOKYO and WASHINGTON, June 1, 2016 – Elekta (EKTA-B.ST) announces that 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 United States. Icon is the world’s most precise and sophisticated system for radiosurgery treatment of certain brain tumors, vascular malformations and functional disorders.
Icon offers physicians increased flexibility by allowing either frame-based or frameless methods to immobilize the patient’s head, while ensuring the highest level of precision. It opens a new paradigm in cancer care for patients with larger brain tumors and lesions close to critical brain structures to be treated with Gamma Knife accuracy and confidence.
“Japan has historically been an important market for Elekta,” says Tomas Puusepp, President and CEO. “The first Gamma Knife was installed in 1990; today, the installed base per capita matches that of the United States. Thanks to the insight and commitment of Japanese physicians, thousands of patients with serious brain disease are living better lives after treatment with Leksell Gamma Knife. Now, with Icon, we expect an even broader range of patients to receive improved care with great outcomes.
“And in the US market, we anticipate meeting the great interest that leading clinics and hospitals have shown in Icon. With the NRC’s licensing guidance approval, all health care providers in the US have access to use Icon and the benefits it offers them and their patients.”
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 The Republic of Korea.
Since Leksell Gamma Knife® was first introduced to Japan in 1990, Gamma Knife radiosurgery has become widely used for the treatment of brain disorders, especially metastatic cancer tumors.
The total number of cancer patients in Japan is estimated at about 980,000 a year[1], approximately 100,000 (10 percent) of whom will develop metastatic brain tumors[2]. Only about 10,000 of these patients receive Gamma Knife treatment each year.[3] Now, with Leksell Gamma Knife Icon, the number of patients who can receive stereotactic radiosurgery to the affected area with unparalleled precision and minimal impact on the surrounding healthy tissue, 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.
To learn more about Leksell Gamma Knife Icon, visit www.careforthebrain.com.
[1] Foundation for Promotion of Cancer Research “Cancer Statistics in Japan 2015”
[2] The Japan Neurosurgical Society website http://square.umin.ac.jp/neuroinf/medical/202.html
[3] Leksell Gamma Knife Society: Gamma Knife Radiosurgery: Leksell Gamma Knife Indication Treated 1968-2014
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For further information, please contact:
Gert van Santen, Group Vice President Corporate Communications, Elekta AB
Tel: +31 653 561 242, e-mail: gert.vansanten@elekta.com
Time zone: CET: Central European Time
Tobias Bülow, Director Financial Communication, Elekta AB
Tel: +46 722 215 017, e-mail: tobias.bulow@elekta.com
Time zone: CET: Central European Time
The above information is such that Elekta AB (publ) shall make public in accordance with the Securities Market Act and/or the Financial Instruments Trading Act. The information was published at 07:30 CET on June 1, 2016.
About Elekta
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both health care providers and patients, Elekta aims to improve, prolong and even save patient lives.
Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,800 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on NASDAQ Stockholm. Website: www.elekta.com.
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