Technology | June 20, 2012

Elekta receives FDA 510(k) clearance for Agility MLC solution


June 20, 2012 — Elekta announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Agility, a beam-shaping device integrated into the head of a linear accelerator (linac). Patients and clinics in the United States will now be able to benefit from the speed and reliability of this new multi-leaf collimator (MLC) design.

“Hundreds of thousands of patients will benefit from this unique device every year. Agility is designed to meet the demands of modern cancer treatment. It’s vital to be able to shape a radiation beam with high precision to avoid harming surrounding tissue, while maintaining time efficiency. Agility has now been in clinical use for some time in Europe with excellent feedback from users,” said Tomas Puusepp, president and CEO of Elekta.

Agility’s leaf speeds are twice as fast as other MLCs commonly used within the industry, meaning shorter treatment times for patients while hospitals and clinics are able to treat patients more efficiently. With twice as many leaves as a standard MLC, Agility will enable clinicians to sculpt delivered radiation doses to the unique contours of tumors with extreme precision. Consequently, Agility’s leaf bank is designed for extraordinarily low transmission.

Agility can be purchased as part of a new radiotherapy solution from Elekta, as well as an upgrade option to a large part of Elekta’s installed base of linear accelerators. This enables clinics to maximize the potential of their existing equipment.

Agility features include:

  • 160 tungsten leaves only 5 mm thin, with a leaf speed of up to 6.5 cm per second;
  • High-performance reliability and precision using Elekta’s Rubicon optical positioning system;
  • Dedicated Integrity R3.0 software, Elekta’s seventh generation digital control system, to precisely coordinate leaf movements with variable dose delivery rates and other treatment parameters;
  • Integrated dynamic leaf guides streamline delivery and eliminate the need for “split fields” commonplace with other MLC systems; and
  • Large-field MLC will enable clinicians to shape radiation across fields of up to 40 x 40 cm, providing a highly versatile single solution for a broad spectrum of therapies.


For more information: www.elekta.com

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