Varian Medical gets FDA approval for Calypso soft tissue Beacon transponder

21 July 2014 (Last Updated July 21st, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based Varian Medical Systems' Calypso soft tissue Beacon transponder that can help improve the precision of radiotherapy and radiosurgery treatments for cancer.

Varian Medical Systems Headquarters

The US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based Varian Medical Systems' Calypso soft tissue Beacon transponder that can help improve the precision of radiotherapy and radiosurgery treatments for cancer.

The new transponders, which are size of a grain of rice, can be implanted within soft tissue throughout the body, with the exception of the lung.

Following implantation, the Calypso GPS for the Body system can continuously track and monitor the position of the transponders, so that the high-energy treatment beams can be precisely aimed to reduce exposure of surrounding healthy tissues.

A previous version of the Calypso Beacon transponder was cleared for use in the prostate and prostatic bed, while the new clearance allows the system to be used in many other types of cancer.

The company said that Calypso Beacon transponders release a non-ionising electromagnetic signal tracked in real-time by the Calypso system, to guide treatment beams to precisely target tumours during radiotherapy and radiosurgery with medical linear accelerators, such as Varian's Edge radiosurgery system.

"Clinicians can use the Calypso system most places they would have used standard fiducial markers to localise a targeted tumour."

Varian Medical Systems Calypso product manager Andrea Morgan said: "With the new transponder, clinicians can use the Calypso system most places they would have used standard fiducial markers, such as gold seeds, to localise a targeted tumour, but with the added benefit of continuous tumour position tracking throughout treatment delivery.

"Other types of fiducial markers have to be localised using X-rays, which add more ionising 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."

According to the company, the new Calypso soft tissue Beacon transponders can only be used with the latest upgrade of the Varian Calypso system (version 3.0), as the existing transponders for the prostate are not suitable for the new soft tissue indication due to device and labelling differences.

The new device will initially be used towards the end this year, while full commercial roll-out of the product will take place sometime in 2015.


Image: Varian Medical Systems headquarters in Palo Alto, California, US. Photo: courtesy of Varian Medical Systems, Inc.