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Nucletron B.V. Receives FDA 510(k) Clearance For Simulix EVOLUTION (TM), An Advanced Digital Solution For Radiation Treatment Planning, Simulation And Verification That Improves The Quality Of Radiation Cancer Therapy


10/19/2005 5:09:58 PM

VEENENDAAL, The Netherlands, February 10 /PRNewswire/ -- Nucletron B.V., one of the world's leading providers of life-saving radiotherapy software and equipment solutions, announces FDA 510(k) USA market clearance for Simulix EVOLUTION(tm), a new digital simulator system designed for integrated planning, verification and simulation of radiation therapy is available as a complete system as well as an upgrade for existing Simulix systems and is already in clinical use in various clinics in Europe.

Robert Brookland MD, FACR, FACRO and is Chief of Radiation Oncology at Greater Baltimore Medical Center, Baltimore, Maryland states, "During our gamma testing for the EVOLUTION Simulator & SIMPLICITY(tm) Workstation we have experienced enhanced clinical workflow in our simulation process. Electronic Simulation streamlines the procedure and reduces the fluoroscopic time for our patients by at least 70%. The integration with Lantis(r)(1) is excellent and for simulation we are now completely film less. This is a tremendous time saver. In addition, SIMPLICITY offers new functionality at the simulator. Making the decision to buy the Simulix simulator from Nucletron in 1999 has prevented us from obsolescence and will allow us to continually move forward with new and future technologies with Nucletron."

Simulix EVOLUTION has undergone successful clinical testing in Europe and the USA, confirming the unsurpassed quality of the system. Mr. Rob van't Hoff from the Reinier de Graaf Hospital in Delft, Holland states, "EVOLUTION is a clear, easy to use system and offers image quality we do not want to do without". From the University of Munster in Germany, Professor Willich comments, "EVOLUTION offers much improved image quality, with better visibility of detail due to the high contrast resolution. The new SIMPLICITY simulator workstation comprehends our clinical workflow very well and offers an easy to use, orderly designed user interface."

"Radiation therapy has seen great advances in the integration of planning, simulation, verification and delivery of radiation therapy as well as the adoption of new approaches like IGRT (Image Guided Radiation Therapy) and IMRT (Intensity Modulated Radiation Therapy)." says Rudolf Scholte President and CEO of Nucletron. "EVOLUTION is a leading edge simulation and verification solution that incorporates an unique combination of superior digital imaging, full functionality and open connectivity that is ideally suited for this fully integrated radiation therapy process."

Mr. Scholte also states, "EVOLUTION includes SIMPLICITY, a new user-friendly PC-based simulator workstation, integrating image handling, plan set-up and verification as well as image and plan import/export. An open architecture based on DICOM-RT and RTP-link standards assures full connectivity to other radiotherapy systems, including those of many other vendors."

(1) Lantis(r) is a registered trademark of Siemens Medical Solutions. About Nucletron B.V.

Nucletron specialises in the development, manufacture, sales, service and support of the world's most innovative products for cancer treatment, with particular expertise in Treatment Planning, Brachytherapy, Information Management, Simulation and Service. The company has 22 offices worldwide, including its corporate headquarters in The Netherlands. For more information on Nucletron, please visit: http://www.nucletron.com/.

Nucletron B.V. is a subsidiary of Delft Instruments N.V. http://www.delftinstruments.com/ Delft Instruments employs some 1,200 people, is listed on Euronext Amsterdam and is included in the NextEconomy segment. The company reported a preliminary net profit of EUR 10.4 million on turnover of around EUR 237 million in 2003.

http://www.nucletron.com/

Nucletron B.V

CONTACT: Mark Adam, V.P. Marketing, Nucletron B.V., The Netherlands,phone +31-318-557-149, fax +31-318-557-199, mam@nucletron.nl,Paula Waddell, Marketing Manager, Nucletron Corporation, USA,phone +1-410-312-4142, fax +1-410-312-4126, waddell@nucusa.com


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