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Dielectric pads for high field MRI

Periodic Reporting for period 1 - MRI PADS (Dielectric pads for high field MRI)

Reporting period: 2019-06-01 to 2020-05-31

Ultra-high field scanners slowly grew from research into clinical use ever since Siemens obtained approvals to use its 7T MRI scanner for head and knee imaging in late 2017. Europe has also staked on their potential, indicated via the new installations of 7T scanners in several hospitals in 2019 such as Erlangen University Clinic (Germany), Poitiers University Hospital (France), and University College Hospital (United Kingdom) among others. Ultra-high field scanners have delivered on their promise – with remarkable improvement in brain images of unprecedented contrast to noise ratio and spatial and/or temporal resolutions. This is a breakthrough for clinical and neuroscientific research; at the same time, however, several limitations have been reported, hindering both the clinical application and market penetration of ultra-high field MRI. At such ultra-high field strengths, the main issue is the inhomogeneities in the transmission phase of the MRI causing heterogeneous excitation of the nuclear spins. This induces shadows or contrast losses in MR images of the human brain, making the impacted regions diagnostically deficient. To tackle these inhomogeneities in ultra-high field MRI, several solutions are under development but due to their complexity, they will need several years to integrate clinical routines. Therefore, the growing market of 7T scanners in Europe is in urgent need of a simple and effective solution to solve this issue. The main objective of this project is to bring to market an efficient, low-cost, safe and durable solution developed during the M-Cube FET-Open project. This project fits in the scope of Europe’s race for its highly competitive position at global level in MRI. By achieving translation from research into clinical application, it will bring on the newly 7T scanners market an effective solution that is not hindered by the drawbacks of the current best solution in the literature (independents RF coils used to modulate the RF signals): manufacturing of complex electronics, adapting imaging sequences, monitoring SAR levels, costs, scanning duration. Therefore, the overall objective of the project is to capitalize on the M-cube project momentum to turn a result obtained into a marketable innovation. To that end, the proof-of-concept prototype developed in the laboratory will be transferred into an industrial level medical device in terms of conception and method of elaboration. Once the industrial process is validated, device safety and usability proofs are produced for its CE marking process. Finally, the device is presented to hospitals and laboratories in order to sell at least 50 units by the end of the project.
By the end of the project, the following sub-objective were cleared:
- a large-scale elaboration process that can be manufactured entirely in Europe with a list of reliable and cost-effective material suppliers was set-up,
- CE marking of the device is scheduled for the following months. Risk assessment and usability were carried out during the project while clinical evaluation is finalized,
- Dissemination expanded the previous framework to more hospital and laboratories which allowed to sell 46 units
- business plan was refined and focused into two main goals : selling through the established framework to research institutes and clinics and contracting a partnership with larger OEM so that our device is sold in their 7T MRI scanner.

During that year, MRI pads were promoted at 3 annual international meetings and a publication with all the latest scientific results was submitted.
The ultimate goal is to bring an efficient medical device to the E.U. market. To that end, setting a marketable prototype from device developed in the framework of a research project was a necessary first step. This differs from a laboratory prototype in that it includes all the aspects of exploitation by the end-user and ergonomics. The protocol of elaboration and prototype obtained during the FET project was fully adapted into a documented industrial process and made into a manufactured prototype.
With the recent CE approval of the Magnetom scanner, Siemens paves the way to clinical routine brain imaging at 7T. This new technology has the capability to enhance diagnosis capabilities for diseases such as epilepsy and multiple sclerosis, which heavily rely on the clear distinction between gray matter and white matter in the brain. Studies regarding neurodegenerative diseases, such as dementia and Parkinson disease, will benefit from those new capacities. Indeed, detailed micro-structures of regions diagnostically deficient, such as hippocampus and/or temporal lobes, will become now accessible. These novel and unique sources of information relevant to various diseases will have a strong impact on society once translation from research into clinical application is achieved for both the scanner and the antennas. Developing this MRI pads medical device, we brought closer to market a promising candidate that will have noticeable impacts on scientific, societal and scientific levels.

First of all, it will greatly boost research capabilities and scientific knowledge in domains such as epilepsy, schizophrenia, Alzheimer… from detailed substructure observation of regions like temporal lobes on patients. Therefore, social impact will arise from early diagnostic abilities and/or earlier treatment coupled with shortened
scan duration per patient in hospitals. Compared with parallel transmission systems, this device is cheaper and simpler to use as they rely on a passive system. Finally, this project reinforced Europe’s industrial leadership in MRI and associated MRI systems by bringing to the table a simpler equipment from a regulation point of view. This means that it will be brought quickly into the market to accompany 7T scanners spread in Europe and USA.
Pads 7TNS