FDA 510(k) Clearance for Varian Medical Systems’ Calypso Soft Tissue Beacon Transponder
Varian Medical Systems today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a Calypso soft tissue Beacon transponder that can help enhance the precision of radiotherapy and radiosurgery treatments for cancer.
The size of a grain of rice, the new transponders can be implanted within soft tissue throughout the body, with the exception of the lung. The Calypso GPS for the Body system can then continuously track and monitor the position of the transponders, so that the high energy treatment beams can be precisely aimed to minimize exposure of surrounding healthy tissues. An earlier version of the Calypso Beacon transponder was cleared for use specifically in the prostate and prostatic bed; the new clearance makes the system applicable for many other types of cancer.
Calypso Beacon transponders emit a non-ionizing electromagnetic signal that is tracked in real time by the Calypso system, in order to guide treatment beams to precisely target tumors during radiotherapy and radiosurgery with medical linear accelerators, such as Varian's Edge radiosurgery system.
"With the new transponder, clinicians can use the Calypso system most places they would have used standard fiducial markers, such as gold seeds, to localize a targeted tumor, but with the added benefit of continuous tumor position tracking throughout treatment delivery," said Andrea Morgan, Calypso product manager. "Other types of fiducial markers have to be localized using X-rays, which add more ionizing radiation to the process. We're pleased to be able to make the system available to clinicians who want to use it more broadly, not just for conventional radiotherapy but for some of the newer approaches, like stereotactic body radiotherapy (SBRT), which involves delivering higher radiation doses very quickly. For treatments like that, accurate targeting is essential, and the new Calypso transponders have an important role to play."
"I have been using standard fiducial markers, particularly when treating tumors of the pancreas and liver," said Mary Feng, MD, associate professor in the Department of Radiation Oncology at the University of Michigan. "It is essential that we know exactly where the tumor is at all times, and that we have a way of responding if the tumor moves during treatment. I'm excited about the prospect of using the Calypso tracking system treating in areas where it is very hard to see the tumor because of the lack of contrast with surrounding soft tissues."
The new Calypso soft tissue Beacon transponders can only be used with the latest upgrade of the Varian Calypso system (version 3.0). Current Calypso Beacon transponders for the prostate are not appropriate for the new soft tissue indication due to device and labeling differences. "Initial use of the new device is expected towards the end of the year," said Corey Zankowski, vice president of product management at Varian. "We anticipate full commercial roll-out of the product sometime next year."
Calypso soft tissue Beacon transponders are cleared for the U.S. market only.