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Varian's EDGE radiosurgery system gets FDA nod

by Loren Bonner, DOTmed News Online Editor | January 25, 2013
Varian's EDGE radiosurgery suite
The U.S. Food and Drug Administration has granted Varian Medical Systems clearance for a new radiosurgery system that the company said will improve tumor tracking and motion management when delivering high doses of radiation to patients during treatment.

"It integrates Varian's state-of-the-art radiosurgery technology with tools for real-time imaging, tracking, and patient positioning," said Chris Toth, vice president of marketing for Varian's Oncology Systems business, in an official statement from the company. "It enables fast, accurate delivery of stereotactic radiosurgery for treating lesions, tumors, and conditions anywhere in the body where radiotherapy is indicated, including tumors of the lung, prostate, spine and brain."

Motion tracking enhancement also helps preserve normal tissue — a critical part of delivering accurate treatment and also opening up new areas like the lung for treatment where radiation can't be used to its full benefit because of motion.

The new package of tools on the system, which can also be made available as upgrades to other compatible Varian systems, is called the EDGE radiosurgery suite and includes five technologies — four of which received the recent stamp of approval by the FDA: a flexible treatment couch to position patients optimally; a real-time imaging package that also includes expanded use of fluoroscopy and 4D cone-beam CT to better compensate for tumor motion during treatment; an integrated intracranial radiosurgery package for treating tumors in the brain; and several enhancements to Varian's real-time tracking system Calypso.

The Calypso anchored Beacon transponder for implantation — or position signaling device to track motion during treatment in the lung — is still pending 510(k).

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