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Elekta VMAT 510(K) Clearance Welcomed By US Radiation Oncologists

June 16, 2008

Regulatory News:

Elekta (STO:EKTAB) has received FDA 510(k) clearances for its groundbreaking Elekta VMAT solution, allowing US cancer specialists to both plan and deliver radiation using a technique which has the potential to revolutionize the practice of radiation oncology. This news has been eagerly anticipated by US cancer clinics as it offers both significant benefits to their patients and the opportunity to increase patient volumes.

From the patient’s perspective, Elekta VMAT (Volumentric intensty Modulated Arc Therapy) combines a significant reduction in treatment time with optimal avoidance of radiation dose to healthy tissues surrounding the tumor. From the doctor’s perspective, the reduction in treatment time makes it much easier to accurately target the tumor and the improved dose sparing offers new options to either increase dose to tumor or reduce side effects and therefore potentially improve outcomes. For the clinic administrator, reduced treatment times and the opportunity to increase dose and reduce the number of treatment sessions increases the number of patients that can be treated using their existing equipment.

Elekta is uniquely positioned to introduce the VMAT technique by virtue of Elekta Synergy(R), the only fully digital linear accelerator with integrated high-resolution 3D X-ray Volume Imaging (XVI). With daily pre-treatment imaging scans, clinicians who implement Elekta VMAT will be able to maximize accuracy and shrink treatment margins, while minimizing the possibility of damage to surrounding healthy tissue.

“Over ten years of research in collaboration with members of the Elekta IMRT Consortium has lead to this unique series of innovations”, explains Tomas Puusepp, President & CEO of Elekta. “Having the worlds only fully digital accelerator is a key element in making this level of automation and control complexity possible in a way that allows clinicians to deliver advanced treatments with a single push of a button. Interest from clinicians in this technology is very high and we believe that VMAT will be the next major technology shift following the introduction of intensity modulated radiation therapy (IMRT) around the millennium and the subsequent introduction of image guided radiation therapy (IGRT)”, Tomas Puusepp concludes.

For more information on Elekta VMAT, please see www.elekta.com/VMAT.

About Elekta

Elekta is an international medical technology group, providing oncologists, radiation therapists, neurosurgeons and many other medical specialists with state of the art tools to fight serious disease.

Elekta provides advanced clinical solutions, comprehensive management and information systems as well as services for improved cancer care and management of brain disorders.

Elekta’s systems and solutions are used in over 5,000 hospitals around the world. Clinical and information management solutions include, among others, Leksell Gamma Knife(R) for non-invasive treatment of brain disorders, Elekta Axesse(TM) and Elekta Synergy(R) for stereotactic and image guided radiation therapy and radiosurgery as well as the MOSAIQ(TM) suite of software for image-enabled EMR and efficient management of clinical and patient data.

With around 2,500 employees globally, the corporate headquarter is located in Stockholm, Sweden and the company is listed on the Nordic Exchange under the ticker EKTAb. More information about Elekta can be found at www.elekta.com.

This information was brought to you by Cision http://newsroom.cision.com




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