For Immediate Release
Calypso Medical Completes First Installation of Dynamic Edge Gating
Washington University first site to incorporate real-time, automated gating as a safeguard against unintended radiation of healthy tissue during prostate cancer treatment
January 13, 2011
Seattle, CA -- Calypso Medical Technologies, Inc., a developer of real-time localization technology used for the precise tracking of tumors, today announced that the Siteman Cancer Center at the Washington University School of Medicine in St. Louis is the first facility in the world to equip their Calypso® System with Dynamic Edge™ Gating technology. This new technology automates the response to organ motion by sending signals to the linear accelerator (the device delivering the radiation) to disable or re-enable the radiation beam during treatment based on the location of the tumor. The safeguard from unintended radiation that Dynamic Edge Gating provides for healthy tissue may lead to a further decrease in the side effects associated with prostate radiotherapy such as bowel and bladder incontinence and sexual dysfunction.
“Since Calypso’s gating solution uses the actual tumor target as a reference point, the resulting signal sent to the linear accelerator about when to hold or turn the beam on is accurate,” said Lakshmi Santanam, Ph.D., assistant professor, department of radiation oncology at Washington University School of Medicine. “With this enhanced capability to automatically manage tumor motion, we’ll have more confidence that our radiation delivery is on target and that adjacent healthy tissue is not compromised. We are very pleased to have this technology available to help guide our daily patient treatment sessions.”
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. Dynamic Edge Gating technology, recently cleared by the U.S. Food and Drug Administration (FDA), 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. The automation of this function eliminates operator subjectivity which results in a more uniform approach to radiation delivery.
“Calypso’s gating technology helps to control the inter-therapist variability inherent in multiple session radiation therapy by automating a previously manual function and basing beam-hold interventions on objective data, specific for each patient,” said Edward Vertatschitsch, president and chief executive officer of Calypso Medical. “Moreover, the added safeguard of Dynamic Edge Gating against unintended radiation will provide peace of mind for both physicians and patients that the prescribed dose of radiation is delivered to the intended target area. We are very pleased to be commencing shipments of this important clinical and safety innovation to the Calypso System.”
The Company announced FDA clearance of Dynamic Edge Gating in October 2010 and introduced the technology to radiation oncologists and physicists at the 52nd Annual Meeting of the American Society for Therapeutic Radiation Oncology (ASTRO) in San Diego in November 2010. Dynamic Edge Gating extends the Calypso System’s safeguard against unnecessary radiation and complements ASTRO’s Target Safely initiative in response to public concern over excessive radiation delivery caused by equipment and operator error. In contrast to other guidance techniques, Calypso’s electromagnetic technology is the only non-ionizing guidance solution to keep the treatment precisely focused on the target without adding unnecessary radiation.
About Calypso Medical
Calypso Medical Technologies, Inc. is a Seattle-based, privately held medical device company. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon electromagnetic transponders) to continuously, accurately and objectively track the location of tumors for improved accuracy and management of radiation therapy delivery. The technology is designed for body-wide cancers commonly treated with radiation therapy. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed, and is the only commercially available real-time tracking system for radiation therapy shown to improve patient outcomes for prostate cancer. The Company has strategic relationships with Varian Medical Systems, Siemens Healthcare, Elekta Corporation and Philips Medical. Additional information can be found at www.calypsomedical.com.
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