Elekta receives FDA 510(k) clearance for Apex dynamic multi-leaf collimator (DMLC)
With its 2.5 mm leaf width across the largest field size (12 x 14 cm) and a convenient attach and detach mechanism, Elekta’s Apex™ DMLC is the right beam shaping solution for clinics that encounter cases in which a stereotactic approach is needed.
“Apex combines the right technical specifications with the ability to be rapidly attached and removed, making it the ideal solution for routine treatment of stereotactic cases throughout the day,” says Kevin Brown, Global Vice President, Scientific Research. “This DMLC also features low transmission, small penumbra and sharp dose gradients – all specifically to facilitate static and dynamic stereotactic treatments of head-and-neck targets.”
The Apex DMLC’s 112 leaves feature a dual focus design, which reduces the penumbra, thereby creating a steep dose fall off, and increasing the linearity across the whole field. To minimize transmission between leaf junctions, Apex was designed with a central axis tongue and groove leaf tip. The DMLC’s 2.5 mm leaf width across the entire 12 x 14 cm field size also improves conformance of the smallest head and neck targets by eliminating the stepping effect between leaf ends, which occurs with wider MLC leaves. In addition, full, independent interdigitation enables treatment of island fields or multiple targets in the same fraction.
The integrated attach and release mechanism of Apex creates a seamless interface to the integrated Elekta MLC radiation head. The new design allows the DMLC to be securely mounted and calibrated quickly and easily using the automated calibration procedure that is provided with the product.
· Compatible with Elekta treatment systems equipped with MLCi™ or MLCi2™
· Supports static, IMRT and dynamic techniques from 6MV to 18MV
· Supports ERGO++™ and Monaco® R3.0
· Validated with MOSAIQ® R2.0
*Approval of indications may vary between different countries. Additional regulatory clearances may be required in some markets.
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. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives.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. Website: www.elekta.com (http://www.elekta.com).
Stina Thorman, Vice President Corporate Communications, Elekta AB
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