ELEKTA AB 2014-11-03
Elekta receives FDA 510(k) clearance for Response automatic gating for prostate cancer cases
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.
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