Siemens Medical Solutions Receives FDA 510(K) Clearance for Next Generation Radiation Therapy Solution

CONCORD, Calif., Jan. 23 /PRNewswire/ -- Siemens Medical Solutions (www.usa.siemens.com/medical) announced it has received FDA 510(k) marketing clearance for the sale and distribution of its most recent innovation in radiation therapy technology, the ARTISTE(TM) Solution.

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Developed by Siemens' Oncology Care Systems, the ARTISTE Solution is a linear accelerator engineered specifically for Adaptive Radiation Therapy (ART). Unique in design, ARTISTE is an integrated imaging and workflow solution that provides a comprehensive portfolio of image-guided and advanced treatment delivery protocols.

This new radiation therapy solution offers clinicians multiple imaging modalities. From Megavoltage (MV) to gold-standard, in-room CT imaging, clinicians can select the optimal imaging application for their treatment approach. Siemens' MVision(TM) Cone Beam Imaging Package delivers outstanding soft-tissue resolution, especially in challenging cases, such as imaging prostheses and with large patients. The CTVision(TM) CT-on-rails System provides in-room, diagnostic quality imaging; thus opening up opportunities to implement benchmark concepts, such as daily re-planning.

"Patient anatomy and tumor size and shape change during the course of treatment, often making it difficult to maximize dosage to target tissue while sparing healthy tissue," said Holger Schmidt, president of Siemens Medical Solutions, Oncology Care Systems Division. "ARTISTE provides both fast, powerful 3D MV imaging and CT high-contrast imaging to help monitor daily changes and enable precise radiation treatment delivery. Along with the improved tumor conformity, high-leaf speed, and low leakage of the new 160 MLC(TM) Multileaf Collimator, ARTISTE empowers clinicians -. offering them the flexibility and assurance they need to deliver optimal care."

ARTISTE's design incorporates an array of proven components that reinforces clinicians' confidence in adapting protocols for each patient. For precise patient positioning, the 550 TxT(TM) Treatment Table meets the growing demand for accuracy and stability, while providing the mechanical strength to accommodate a patient weight capacity of up to 550 lbs (250 kg). The ARTISTE Solution is further enhanced by Siemens' comprehensive software solution, syngo(R) Suite for Oncology, a workflow platform providing scalable workspaces that enable clinical team members to access data, patient information, and images as needed.

"Worldwide demographics continue to change and healthcare demands are on the rise. Higher cancer rates and the increasing need for radiation therapy solutions pose many questions, and Siemens has answers," said Schmidt. "With innovations like ARTISTE, we provide the reliability and options that support optimized radiation therapy and simplified clinical workflow, as well as a clear upgrade path for the incorporation of changes in clinical scope and future treatment advances."

Siemens is one of the world's largest suppliers to the healthcare industry. The company is a renowned medical solutions provider with core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology and system integration. With its laboratory diagnostics acquisitions, Siemens will be the first fully integrated diagnostics company, bringing together imaging and lab diagnostics, therapy, and healthcare information technology solutions, supplemented by consulting and support services. The company delivers solutions across the entire continuum of care -- from prevention and early detection, to diagnosis, therapy and care. Siemens Healthcare employs more than 49,000 people worldwide and operates in 130 countries. According to IFRS, in the fiscal year 2007 (Sept. 30), Siemens Medical Solutions reported sales of euro 9.85 billion, orders of euro 10.27 billion, and group profit of euro 1.32 billion (preliminary figures, unaudited). Further information can be found by visiting http://www.siemens.com/medical.





CONTACT: Thomas Schaffner, Siemens Medical Solutions, +1-610-448-1477,
thomas.schaffner@siemens.com

Web site: http://www.usa.siemens.com/medical/

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