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Elekta’s Agility Radiation Therapy Beam-Shaping Innovation For Cancer Treatments Receives U.S. 510(k) Clearance

Utilizing new and faster technology, Agility multi-leaf collimator (MLC) expected to further improve therapy for oncology patients, accelerate treatment times

Using a combination of 160 high-resolution tungsten leaves and dramatically faster leaf movement, Elekta’s revolutionary new Agility™* MLC promises a new level of precision and delivery speed in radiation therapy treatments for cancer patients. Elekta recently received 510(k) clearance (K121328) from the U.S. Food and Drug Administration (FDA) for Agility, enabling U.S. medical centers to provide these clinical benefits to their patients with cancer.

An MLC, a device made up of numerous, individual tungsten “leaves,” is used to shape beams of therapeutic radiation that are delivered from different angles around the patient. Using twice the number of leaves typical of many standard MLC’s, Agility precisely sculpts delivered radiation to the unique contours of the tumor, while reducing the risk of exposure to healthy tissue.

The new Agility MLC also includes ultra-fast leaf movements – twice as fast as other MLCs commonly used in the industry – enabling clinicians to further exploit the most advanced cancer therapies such as stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT) and Volumetric Modulated Arc Therapy (VMAT). Further, with a new lower radiation leakage design, research has shown Agility can significantly reduce the patient’s non-therapeutic radiation exposure as compared to other conventional MLC’s.

“Culminating from years of close collaboration with our worldwide clinical partners, we are extremely proud to introduce Agility in the United States,” says Jay Hoey, Executive Vice President, Elekta North America. “With Agility, not only will treatment times be faster, but more importantly, patients also will benefit from this solution’s enhanced targeting capabilities, which are expected to improve treatment outcomes as well as reduce the risk of potential complications. The promise of these critical patient benefits has generated a great deal of interest in the U.S. radiation oncology community, which we predict will result in rapid adoption of this technology.”

Soon after Elekta received CE marking for Agility, permitting sales of the device in Europe, clinicians began reporting significant gains in beam-shaping ability and delivery speed. Shorter treatment times have resulted in increased patient comfort and convenience, as well as improved the ability for caregivers to treat more patients each day.

*Agility is not licensed for sale in all markets. Please contact your local representative for details.

Source

“Physical characterization of a new concept design of an Elekta Radiation Head with integrated 160-leaf multi-leaf collimator”, Cosgrove, VP, Thompson, C, Chrisophides, D et al. (2009)
Poster presented at ASTRO 2009.

Source: Elekta