Varian Medical Systems received FDA 510(k) clearance for its Calypso soft tissue Beacon transponder. The device, about the size of a grain of rice, is designed to be implanted in soft tissue (except the lungs) to serve as a guide during radiotherapy and radiosurgery procedures. The device emits a non-ionizing RF signal that the Varian Calypso system, a tool for guiding radiation beams, is able to track in real time. The Beacon is particularly useful in radiation oncology for organs that have a tendency to change shape and move around a bit. It provides objective location information to the physicians, helping to bridge imaging and identification of tumors with the subsequent treatment while keeping the target in sights.
The Beacon transponder previously received FDA clearance to be used in the prostate and prostatic bed, but the new clearance expands the indication to any soft tissue except the lungs.
From the announcement:
“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.”
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.
Product page: Calypso System…
Press release: Varian Medical Systems Receives FDA 510(k) Clearance for Calypso® Soft Tissue Beacon® Transponder…
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