News | October 20, 2010

FDA Approves Safeguard for Prostate Cancer Radiotherapy

October 20, 2010 – The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a system designed to automate the response to organ motion during prostate cancer radiotherapy. The Calypso System, by Calypso Medical Technologies, could help decrease the side effects associated with prostate radiotherapy, such as bowel and bladder incontinence and sexual dysfunction.

The system, and its GPS for the Body technology, utilizes miniature implanted Beacon transponders to provide precise, continuous information on the location of the tumor during external beam radiation therapy. The real-time position information provided by the Calypso System allows physicians to deliver maximum radiation directly to the tumor while sparing the surrounding healthy tissues and organs from exposure.

The new gating technology allows therapists to set motion thresholds which automatically signal radiation delivery to be stopped each time the targeted tissue moves outside the preset threshold. Previously, the therapist had to manually intervene and halt radiation delivery when healthy tissue was in danger of receiving unintended radiation. Dynamic Edge Gating Technology automates this function with an immediate signal to the linear accelerator so the radiation beam can be disabled or re-enabled in response to organ motion.

Side effects occur when the tumor moves outside of the radiation field in response to normal physiologic processes such as digestion, coughing and breathing, as well as small movements by the patient. As a result, healthy tissue receives the intended radiation, and at the same time, the tumor fails to receive the fully prescribed radiation dose.

"Calypso's Dynamic Edge Gating Technology is the next step in addressing organ motion for our patients," said Parag Parikh, M.D., assistant professor of radiation oncology at Washington University in St. Louis. "By automatically turning off the radiation beam if the target moves out of the planned location, this allows new ways to minimize the irradiation of healthy tissue, leading to better outcomes and quality of life for our patients."

In May 2010, Urology published a study that demonstrated that patients whose radiation therapy delivery was guided by the Calypso System experienced a significant decrease in the side effects associated with prostate radiation treatment.

For more information: www.calypsomedical.com

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