Medical Reading

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

July 19, 2017

Calypso Medical Technologies, Inc., a developer of real-time localization technology used for the precise tracking of tumors, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Calypso® System with Dynamic Edge™ 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. 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.

"The automatic response of the Calypso System to organ motion results in benefits to both the patient and the department," said Lorraine Marshall Wright, chief marketing officer and vice president of Calypso Medical. "Holding the radiation beam when the target is outside of clinician-defined limits results in a safer, more uniform approach to radiation delivery, which may lead to a decrease in the side effects of prostate radiotherapy. Additionally, as with any automated process, improvements in workflow efficiency will be appreciated for maximizing throughput and enhancing the patient experience."

Side effects result 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, while radiation is being delivered. As a result, healthy tissue receives the intended radiation, and at the same time, the tumor fails to receive the fully prescribed radiation dose thereby compromising effectiveness of the therapy. While some side effects may resolve over time, many do not, leaving the patient with a significant impact to their quality of life.

"Calypso's Dynamic Edge Gating Technology is the next step in addressing organ motion for our patients," said Dr. Parag Parikh, 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, 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. Using Calypso's real-time tracking technology, physicians were able to decrease the margin of healthy tissue that surrounds the tumor target to just a few millimeters. Irradiating less healthy tissue resulted in fewer side effects. The combination of the decreased target margins demonstrated in the AIM study and the automated radiation beam response of Dynamic Edge Gating has the potential to further reduce prostate radiation therapy side effects since the radiation beam will now be enabled or disabled automatically, based on objective motion threshold data, as opposed to manual intervention by the therapist.

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. The Calypso System is the only commercially available real-time tracking system for radiation therapy shown to improve patient outcomes for prostate cancer.

Source:
Calypso Medical Technologies, Inc.