The U.S. Food and Drug Administration (FDA), granted 510(k) pre-market clearance to the Elekta Synergy system from Elekta. This means that Elekta can now market and sell the system also in the U.S. In Europe, Elekta Synergy 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, 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 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 system. In addition to NKI, three other leading cancer clinics in Great Britain, Canada and USA have research installations of Elekta Synergy.
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 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 tumor during treatment, the image quality and treatment accuracy is significantly improved.
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 adds dedicated imaging technology to a proven treatment platform, creating a system that is truly more than the sum of its parts."