Elekta receives FDA 510(k) clearance for Response automatic gating for prostate cancer cases

ATLANTA, Nov. 3, 2014 — (PRNewswire) — Elekta's (EKTA-B.ST) Clarity^® 4D prostate monitoring system can now automatically interrupt, or "gate," the radiation beam when it detects that the prostate has moved out of position. Clarity 4D Monitoring software has enabled doctors to continuously visualize the prostate's precise location during radiation therapy. FDA 510(k) clearance for Clarity to be used with Elekta's Response gating interface will give US physicians the potential to further safeguard the patient's normal tissues from overexposure to radiation during prostate radiotherapy. The feature is available as an option with Elekta's advanced Versa HD™ radiation therapy treatment system.

Reliably localizing the prostate is critical during precision radiotherapy, as dose is being constantly delivered to its assumed location even though the prostate's position may be changing due to pressure from surrounding anatomy such as the bladder or rectum.

"The Clarity system permits clinicians to set the amount of prostate movement allowable over a given period, for example, three or five millimeters for a five-second period, depending on the dose rate and other factors," explains Tony Falco, Senior Vice President, Elekta Software. "When Clarity detects anything over this limit, the treatment is automatically paused to allow clinicians to correct for the motion. This could be especially important for clinicians pursuing advanced prostate protocols, such as reduced margin hypofractionated therapy or stereotactic body radiation therapy [SBRT]." 

Automated beam gating with Response will also help streamline prostate radiotherapy workflow by removing the human reaction time to prostate position alerts, he adds.

For further information, please contact:
Gert van Santen, Group Vice President Corporate Communications, Elekta AB
Tel: +31 653 561 242, e-mail: Email Contact
Time zone: CET: Central European Time

Kris Walmsley, Corporate Communications Manager, Elekta AB
Tel: +46 70 537 9545, e-mail: Email Contact
Time zone: CET: Central European 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 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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