Stockholm, 28 October 2003 Images available - see below!
ELEKTA RECEIVES FDA CLEARANCE FOR ELEKTA SYNERGY(TM)
The revolutionary new radiotherapy system from Elekta is first to
combine x-ray volume imaging and treatment in a single platform
On Monday the 27 October, the U.S. Food and Drug Administration (FDA),
granted 510(k) pre-market clearance to the Elekta Synergy(TM) System
from Elekta. This means that Elekta can now market and sell the system
also in the U.S. In Europe, Elekta Synergy(TM) is already marketed,
following CE marking in July 2003.
In research and development over the last five years, this new
radiotherapy treatment platform directly addresses the two most
persistent and significant problems in modern radiation therapy:
internal organ motion and errors in patient set-up.
Elekta was the first vendor to start research on image-guided radiation
therapy, the first to have systems in clinical use, and the first to
bring these solutions to the market.
"With the introduction of Elekta Synergy(TM), Elekta is leading the
efforts to increase the precision of radiotherapy delivery by limiting
or even eliminating the impact of the patient's internal organ motion
and how the patient is set up for treatment from day to day", says Peter
J. Gaccione, vice president Oncology Sales and Service Operations for
Elekta North America.
Elekta Synergy(TM) does this by using innovative x-ray volume imaging
technology that is integrated directly onto the treatment system itself.
This means that routine pre-treatment imaging of a tumor can now be
performed immediately prior to treatment, decreasing the risk that a
tumor or internal organs will change position. In addition, since the
patient doesn't have to be moved from an imaging device (e.g. MR, CT) to
the radiotherapy treatment machine, the problem of errors from patient
re-setup are eliminated.
The first use of this new class of Image Guided Radiation Therapy (IGRT)
technology took place at the Netherlands Cancer Institute (NKI) in July
2003, when three cancer patients were treated using the Elekta
Synergy(TM) system. In addition to NKI, three other leading cancer
clinics in Great Britain, Canada and USA have research installations of
Clinical data presented both at the recent ASTRO annual meeting in the
U.S. and the European ESTRO meeting, demonstrate the enormous potential
for the new Elekta Synergy(TM) system to significantly advance
radiotherapy treatment for cancer patients.
It has been shown that by combining an X-ray volume imaging system and
radiotherapy equipment (a medical accelerator) to provide 'real time'
images of the tumour during treatment, the image quality and treatment
accuracy is significantly improved. (ref:1,2)
Volker Stieber, Elekta's Executive Vice President - Technology
Development & Operations, acknowledged the aptness of the new product's
name, "Synergy is defined as two or more entities working together,
wherein the sum is greater than each individual's contribution. Elekta
Synergy(TM) adds dedicated imaging technology to a proven treatment
platform, creating a system that is truly more than the sum of its
International: Peter Ejemyr, Group VP Corporate Communications, Elekta
AB (publ), Phone: +46 8 587 254 00, e-mail: firstname.lastname@example.org
United States: Lars Jonsteg, VP Investor Relations North America,
Elekta, USA Phone: +1 770-670-2419, e-mail: email@example.com
Press contact U.S:
Michelle Lee, PR and Advertising Manager
Tel: +1 770-300-9725 x 277, Fax: +1 770-448-6338
Notes to editors:
· For further information regarding Elekta Synergy(TM) and other Elekta
products, please visit www.elekta.com
· Images of Elekta Synergy(TM) can be accessed at the following website
Elekta is a world-leading supplier of advanced and innovative radiationoncology and neurosurgery solutions and services for precise treatmentof cancer and brain disorders. Elekta's solutions are clinicallyeffective, cost efficient and gentle to the patient.References:1. Oldham M, et al. Online volumetric CT-guided radiation therapy.Abstract 101. American Society for Therapeutic Radiology and OncologyAnnual Meeting, October 2003.2. Letourneau D, et al. Implementation of an on-board kilovoltage cone-beam CT imaging system for clinical applications. Abstract 102. AmericanSociety for Therapeutic Radiology and Oncology Annual Meeting 2003.This information was brought to you by Waymaker http://www.waymaker.netThe following files are available for download:http://www.waymaker.net/bitonline/2003/10/28/20031028BIT01180/wkr0001.dochttp://www.waymaker.net/bitonline/2003/10/28/20031028BIT01180/wkr0002.pdf