Elekta Receives U.S. FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System for Cancer Treatment

Thu Apr 11, 2013 9:13am EDT

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Groundbreaking linear accelerator provides single system versatility to deliver
sophisticated treatments for more patients and cancer types
ATLANTA,  April 11, 2013  /PRNewswire/ -- Elekta recently received 510(k)
clearance from the U.S. Food and Drug Administration (FDA), allowing the company
to begin shipping and installation of all components of the Versa HD system
within  the United States. Featuring high precision beam shaping and tumor
targeting, and capable of delivering radiation doses three times faster than
previous Elekta linear accelerators, Versa HD sets a higher benchmark for cancer
treatment.  

"We are delighted to receive FDA clearance," says  Jay Hoey, Executive Vice
President,  Elekta North America. "The potential clinical benefits for patients
are significant. Further, the operational benefits for clinicians and providers
are eagerly anticipated."  

Uniting high dose rate delivery with rapid MLC leaf speed
Fully integrated with the Agility 160-leaf multileaf collimator (MLC), Versa HD
provides high-definition, high-speed beam shaping over a versatile 40 X 40 cm
field. This unique combination of fast MLC leaf speed with the new High Dose
Rate mode empowers clinicians to fully exploit high dose rate delivery and take
advanced therapies such as VMAT, SRS and SRT to new levels - without
compromising treatment times.  

Versa HD also features:

* Industry-leading safety innovations  
* Customizable, disease-specific configurations  
* Modern patient-friendly ergonomics  
* Fewer delays and downtime with real-time remote system monitoring  
* Low environmental impact, low energy consumption design

Learn more at  www.versahd.com.

Versa HD is not available for sale or distribution in all regions.  Please
contact your local Elekta representative for details.

For further information, please contact:
Johan Andersson Melbi, Director, Investor Relations,  Elekta AB
Tel: +46 702 100 451, email:  johan.anderssonmelbi@elekta.com  
Time zone: CET: Central European Time

Michelle Joiner, Director, Global Public Relations and Brand Management, Elekta 

Tel: +1 770-670-2447, email:  michelle.joiner@elekta.com
Time zone: ET: Eastern Time

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 healthcare 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 3,400 employees globally. The
corporate headquarters is located in  Stockholm, Sweden, and the company is
listed on the Nordic Exchange under the ticker EKTAb. Website:  www.elekta.com.

SOURCE  Elekta

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