Elekta receives US 510(k) clearance for its latest generation intracranial radiosurgery system, Leksell Gamma Knife Icon
August 5, 2015 | By Business Wire News
ATLANTA
Regulatory News:
Elekta’s Leksell Gamma Knife® Icon™ radiosurgery system has received 510(k) clearance from the US Food and Drug Administration, enabling US health care 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 immobilize 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.
For more information on Icon, visit www.careforthebrain.com.
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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 16:15 CET on August 5, 2015. 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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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
or
Johan Andersson, Director, Investor Relations,
Elekta AB
Tel: +46 702 100 451
e-mail: johan.andersson@elekta.com
Time zone: CET: Central European Time
