Varian receives 510 (k) FDA for soft tissue Calypso Beacon transponder -
Varian Medical Systems (NYSE: VAR) today announced it has received 510 (k) of the Food and Drug administration (FDA) for soft tissue Calypso® BEACON® transponder that can help improve the accuracy of radiotherapy and radiosurgery treatments for cancer.
the size of a grain of rice, the new transponders may be implanted in the soft tissue in the body except the lung. GPS Calypso Body® the system can continuously monitor and control the position of the transponders, so that the high energy treatment beams can be precisely to minimize the exposure of surrounding healthy tissue. An earlier version of Calypso Beacon transponder was authorized for a specific use of the prostate and prostate bed; the new game system makes it applicable to many other types of cancer.
Calypso Beacon transponders emit non-ionizing electromagnetic signal that is followed in real time by the Calypso system to guide the treatment beam to precisely target tumors during radiotherapy and radiosurgery with medical linear accelerators such as Edge ™ radiosurgery system from Varian.
"with the new transponder, clinicians can use the Calypso system most places they would have used standard reference markers, such as gold seeds, to locate a targeted tumor, but with additional advantage of the position of the tumor continues to follow throughout the delivery process, "said Andrea Morgan, product manager Calypso." other types of reference markers must be located using X-rays, that add more ionizing radiation in the process. We are pleased to be able to make the system available to clinicians who want to use more widely, not only for conventional radiotherapy, but some of the new approaches, such as body stereotactic radiotherapy (SBRT), which is to deliver radiation doses higher very quickly. for treatments like this, precise targeting is essential, and new Calypso transponders have an important role to play. "
" I use standard benchmarks markers, especially for the treatment of tumors of the pancreas and liver, "said Mary Feng, MD, associate professor in the radiation oncology department at the University of Michigan . "It is essential that we know exactly where the tumor is at any time, and we have a way to respond if tumor motion during treatment. I am excited to use the treatment in areas where it is the Calypso tracking system very difficult to see the tumor due to lack of contrast with the surrounding soft tissues. "
new Calypso transponders soft tissue Beacon can be used with the latest upgrade Varian Calypso system (version 3.0). Beacon transponders current Calypso for prostate are not suitable for the new indication of soft tissues due to different devices and labeling. "The first use of the new device is expected towards the end of the year," said Corey Zankowski, vice president of product management at Varian. "We expect full commercial deployment times next year's product."
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