CIVCO Announces FDA 510(k) Clearance of Protura™ Robotic Patient Positioning System Integration With Varian Medical Systems Clinac® iX and Trilogy® Linacs

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CIVCO Announces FDA 510(k) Clearance of Protura™ Robotic Patient Positioning System Integration with Varian Clinac® iX and Trilogy® Linacs

CORALVILLE, Iowa, Oct. 7, 2013 /PRNewswire/ -- CIVCO Medical Solutions, the leading provider of radiation oncology motion management solutions, is pleased to announce U.S. Food and Drug Administration 510(k) clearance of ProturaTM Robotic Patient Positioning System integration with Varian Medical Systems' Motion Management Interface.

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Protura remotely repositions patients with robotic 6 degrees of freedom to ensure sub-millimeter positioning accuracy. Protura's integration with the Varian Motion Management Interface automatically opens the relevant patient information in Protura software, drawing it from Varian's 4DTC System, automatically loads patient shift data to match Varian's On-Board Imager kV imaging system (OBI), and automatically imports the Varian pedestal location.

"The integration with Protura will provide our Clinac iX and Trilogy users with a safe and efficient workflow for 6DOF patient set-up corrections," said Kevin O'Reilly, senior director of marketing at Varian. "The software automation simplifies applying robotic corrections with seamless implementation for all IGRT procedures. Continued integration with CIVCO's motion management platform will allow Varian users to immobilize and then provide controlled 6D correction, thus fully utilizing the benefits of their Varian treatment system."

"This integration represents each organization's strong commitment to provide radiation oncology professionals with advanced robotic 6 degrees of freedom technology," said Nat Geissel, senior vice president and general manager of CIVCO's radiation oncology division. "Protura is optimized to handle the rigors of a busy clinic while improving efficiency and throughput."

The first clinical use of the Protura and Varian integration has been the Universita Cattolica Sacro Cuore Policlinico (UCSC) "A.Gemelli," Managing Director Professor V. Valentini at Rome, Italy, where over the past year the clinic has been evaluating the impact of the Protura system in a high volume radiotherapy center, surveying geometrical, dosimetric, management and clinical parameters.

"The recent integration with Varian allows our facility to set up patients with essentially no time added to our treatment workflow while improving quality assurance with no manual data entry," said Dr. Silvia Chiesa, MD, Radiation Oncology Department at UCSC. "Modern treatment techniques require high precision and accuracy levels, therefore correct patient positioning is becoming one of the most important issues in radiation oncology. The Protura System is friendly, allowing a fast learning curve and naturally integrates into our daily clinical practice with no changes to our IGRT workflow. "

For more information regarding the Protura and Varian integration contact CIVCO.

About CIVCO
CIVCO Medical Solutions has over 30 years of experience and offers cutting-edge medical technology to a diverse group of medical professionals. CIVCO's Radiation Oncology (RO) division designs, manufactures and markets comprehensive motion management solutions to improve patient outcomes and increase clinical productivity for head & neck, breast, lung, abdomen, prostate and other treatment sites. RO's products include couchtops and overlays for linear accelerators and imaging systems, advanced patient immobilization solutions, robotic patient positioning, advanced fiducial markers, and immobilization/positioning equipment and consumables. The Multi-Modality Imaging (MMI) unit designs and manufactures accessories for use in diagnostic and therapeutic imaging and interventional procedures, with a strong focus on ultrasound. MMI's products range from infection control products including a wide range of ultrasound and CT covers to device guidance, positioning and electromagnetic needle tracking. CIVCO offers patients and clinicians the newest and best technology available to improve patient care. Corporate information is available at www.civco.com.

For further information please contact:
Kelly Hazelett
Marketing Communications Specialist
CIVCO Medical Solutions
Tel: 319-248-6529
kelly.hazelett@CIVCO.com

COPYRIGHT © 2013. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. PROTURA IS A TRADEMARK OF CIVCO. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. NOT ALL PRODUCTS MAY BE AVAILABLE IN ALL MARKETS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2013C0891

SOURCE CIVCO Medical Solutions



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