Calypso Medical out of Seattle won FDA clearance for Dynamic Edge gating technology to automatically control the linear accelerator beam during radiation therapy procedures. Using implanted electromagnetic transponders, the Calypso System can monitor the movement of organs and, thanks to the new approval, will now automatically turn off the beam when in striking range of healthy tissue.
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. 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. The Dynamic Edge Gating feature will be compatible with linear accelerators, the equipment that produces the radiation beam, manufactured by Siemens Medical and Varian Medical Systems.
In May 2010, Urology, a scientific peer-reviewed journal, published a novel study which 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. The study, entitled “Assessing the Impact of Margin Reduction (AIM),” compared Calypso prostate radiation treatment to conventional prostate radiation treatment.
Press release: Calypso Medical Receives FDA 510(k) Clearance for Dynamic Edge Gating Technology…