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US FDA 510(k) clearance for Elekta's Fraxion
Atlanta | Tuesday, February 21, 2012, 10:00 Hrs  [IST]

Elekta, a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders, has receives US Food and Drug Administration (US FDA) 510(k) clearance for Fraxion, a first innovative system that integrates all proven cranial immobilization options in a single solution. The Fraxion head frame helps ensuring accuracy and precision in stereotactic radiation therapy (SRT) of cancer targets in the brain and cranium.

“Building on more than 60 years of stereotaxy experience, Fraxion provides the accuracy and precision that clinicians need for even the most challenging cranial SRT cases,” says Dee Mathieson, senior vice president, Oncology Business Line Management. “Coupled with Elekta's state-of-the-art Monaco treatment planning and an unequalled specification for high resolution beam shaping with Apex, Elekta's latest multi-leaf collimator, these solutions provide our clinical users with a simple, efficient way to expand their practice into stereotaxy.”

Clinicians at Royal Preston Hospital's Rosemere Cancer Centre (Preston, UK) have been impressed by the head frame's ease of use, accuracy and patient comfort.

“Fraxion integrates well into our Elekta environment,” says Glyn Shentall, Head of Radiotherapy Physics at the Royal Preston Hospital. “The head frame is a non-invasive, well-tolerated system that provides high intra-fraction immobilization accuracy. Patient setup for treatment is straightforward and radiographer confidence in the system is high.”

Fraxion head fixation can be used for virtually any patient. The patient can be immobilized with a thermoplastic mask, with the vacuum mouthpiece, or even a combination of both systems. Precise repositioning is possible as the system is directly connected to the treatment table and micro adjustments are possible via easily accessible screws for full 6D patient positioning.

The partial and full head thermoplastic masks provide alternative immobilization options for non-invasive setup, without compromising accuracy. Combining the thermoplastic mask with the vacuum mouthpiece increases flexibility in setup options, allowing optimal setup based on the patient's needs.

“With an estimated patient workload of 72 stereotactic cases per year, the new Elekta Fraxion and Apex equipment provide a flexible solution for a problem many departments face: an increased requirement for highly conformal techniques whilst still maintaining an optimal patient throughput,” Glyn Shentall notes.

Elekta aims to improve, prolong and even save patient lives and develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care.

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