Jun 15, 2012
Elekta receives FDA 510(k) clearance for Agility MLC
STOCKHOLM, SWEDEN, 14 June 2012 – Elekta announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Agility™*, a revolutionary beam-shaping device integrated into the head of a linear accelerator (linac). Patients and clinics in the US will now be able to benefit from the speed and reliability of this new MLC design. Elekta has collaborated closely with leading hospitals and research institutions to develop a solution that can increase the throughput of patients while delivering outstanding precision.
Elekta’s President and CEO, Tomas Puusepp, comments: “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.”
Agility’s leaf speeds are twice as fast as other MLCs commonly used within the industry. This means 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. Reducing unwanted dose to healthy tissue or organs at risk is of primary importance. 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 5mm thin, with a leaf speed of up to 6.5cm per second.
• High-performance reliability and precision using Elekta’s novel 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.
• Large-field MLC will enable clinicians to shape radiation across fields of up to 40 x 40cm, providing a highly versatile single solution for a broad spectrum of therapies.
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company 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.
Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,300 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker EKTAb.