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Clinical Approval for 7-Tesla Scanner

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[Translate to English:] Bild: Siemens Healthineers

(Vienna, 28 August 2017) The "Magnetom Terra" 7-Tesla magnetic resonance imaging (MRI) scanner made by Siemens Healthineers has obtained CE certification. That makes Magnetom Terra the very first clinically approved ultra-high-field MRI scanner and provides a new clinical field strength for magnetic resonance imaging. European users are now able to use the system for routine neurological and musculoskeletal scans. The development process was to a large extent scientifically supported by the Center of Excellence for High-Field MR at the Medical University of Vienna.

The new CE certification means that the product fulfils all EU requirements in terms of safety, clinical utility and environmental protection. "Fifteen years after the 3-Tesla scanner became established, this Clinical approval allows us to extend our diagnostic MRI capabilities to include a new field strength, thereby enabling us to reach a new level of anatomical and functional detail, which will smooth the path towards precision medicine," says Christoph Zindel, Senior Vice President and Head of MRI Business at Siemens Healthineers.

New diagnostic possibilities for epilepsy and multiple sclerosis
Thanks to its very high spatial and spectral resolution, Magnetom Terra provides detailed images of the human locomotor system, accurately displays metabolic processes in the brain and also helps to visualise neurological diseases such as Alzheimer's, epilepsy and multiple sclerosis (MS). Ultra-high-field imaging is particularly advantageous when it comes to brain scans. Because of the higher resolution and greater image contrast it offers, 7-Tesla makes it much easier to identify lesions.
For example when scanning epilepsy patients, where the better differentiation between white and grey brain matter offers new diagnostic possibilities that would hardly be possible at lower field strengths. People with MS also benefit from the 7-Tesla results, because it is easier to see the lesions in the grey matter of the brain, which can potentially lead to cognitive impairment. Because of the combination of better signal-to-noise ratio, greater tissue contrast and higher spatial resolution, 7-Tesla makes it possible to see things that could not be seen at 3-Tesla.

"The ability to use 7-Tesla technology in clinical practice represents a breakthrough in the broad clinical application of 7-Tesla. CE certification is also validated by the huge advances that have been made in new high-frequency technologies and MR techniques, which mean that, in future, it will be technically possible to perform whole-body scans. This will encourage the transition from research use to clinical application," says Siegfried Trattnig, Head of the Center of Excellence for High-Field MR at the Medical University of Vienna. "The higher signal-to-noise ratio, enhanced contrast and non-proton-based MR imaging offered by 7-Tesla will result in improved spatial and temporal resolution but, more importantly, to improved biochemical and metabolic tissue characterisation – on the way to non-invasive personalised clinical medicine."

Dual mode functionality allows both clinical and research use
The dual mode functionality of the Magnetom Terra enables users to switch easily between clinical protocols and innovative research techniques. This makes the system an ideal platform for translational research and allows the use of 7-Tesla imaging to be extended, for example to include whole-body applications. So far, 7T has been used for investigating and improving the visibility of extremely small pathologies in the field of anatomical imaging and for subcortical brain activity in the field of functional imaging. The exploration of patients' metabolism will play a greater role in the future. In this case the 7-Tesla system could be likened to a kind of MR microscope that explores the anatomy, function and metabolism of body tissue. The open system architecture is particularly interesting for research purposes, since it enables users to run their own developments on the Magnetom Terra and to build on them.

The important contribution made by MedUni Vienna
The Medical University of Vienna was able to use the 7T scanner in the MR High-Field Center to have a decisive influence upon development, since the 7T was used in comparative clinical trials with 3T at a very early stage. "While other 7T centres focused on developing the hardware and primarily on neurological basic research, in Vienna we conducted a series of clinical trials focussing not only on neurological applications but also whole-body applications at 7T (joints, liver, kidneys, breasts etc.)," explains Siegfried Trattnig. "Vienna is the top international site when it comes to clinical trials at 7T."
The results of the 7T trials, documented in a number of prestigious publications, encouraged Siemens to manufacture its own 7T solenoids and to develop a clinical 7T MRI scanner that could obtain CE certification and FDA approval, like the routine 1.5 and 3T MRI scanners, which has now happened.
For the approval process Siemens asked the Vienna researchers to conduct two large-scale comparative studies in the neurological and musculoskeletal area, in order to show the superiority of 7T over clinical 3T MRI scanners in routine clinical trials. The results of these two studies were published in leading journals and might ultimately have contributed to the success in obtaining FDA approval and CE certification.

Comparison of Routine Brain Imaging at 3 T and 7 T.
Springer E, Dymerska B, Cardoso PL, Robinson SD, Weisstanner C, Wiest R, Schmitt B, Trattnig S.
Invest Radiol. 2016 Aug;51(8):469-82
Comparison of Routine Knee Magnetic Resonance Imaging at 3 T and 7 T.
Springer E, Bohndorf K, Juras V, Szomolanyi P, Zbýň Š, Schreiner MM, Schmitt B, Trattnig S.
Invest Radiol. 2017 Jan;52(1):42-54