Calypso Medical Receives FDA 510(k) Clearance for Dynamic Edge Gating Technology

SEATTLE—Oct. 7, 2010—Calypso Medical Technologies, Inc., a developer of real-time localization technology used for the precise tracking of tumors, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Calypso® System with Dynamic Edge(tm) Gating Technology. This latest innovation of the Calypso System automates the response to organ motion that occurs during the delivery of radiation to prostate cancer tumors in order to protect healthy tissue from unintended radiation. As a result, this technology may enable a further decrease in the side effects associated with prostate radiotherapy, such as bowel and bladder incontinence and sexual dysfunction.

The Calypso System, with 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 Calypso System, which provides target position information in the form of objective data, relied upon the therapist to manually intervene and halt radiation delivery when healthy tissue was in danger of receiving unintended radiation.

source: Calypso Medical