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End of StimulAIS project

tipo de documento Artículo

After technological development stages, three main results have been successfully achieved and integrated in a working active implantable medical device, in accordance with EU directives, for performing customized treatment of AIS:

  • R1. Implantable device (with associated stimulation control software and charger)
  • R2. MIS instruments
  • R3. External console

 

R1. The implantable device is programmable (for sensing and stimulating) in order to provide a wide range of treatment protocols, while muscle selectivity will allow targeted stimulation to maximize treatment outcome. Moreover, the integrated stimulation control software (to modulate it into safety thresholds) implements an innovative technology with sensor (EMG) and motor function, which will allow real-time adaptation in order to maintain stimulation effectiveness and provide progressive correction of the pathology.

All these features are integrated in a small device with low obtrusiveness providing the advantages of fully implanted systems with a minimally invasive associated procedure.

R2. Specific surgical instruments were developed in order to implant the electro-stimulation device and for the connection of electrodes to the key muscles. The minimally invasive surgical technique was validated in-vitro with the developed instruments, and ensures a short hospital stay.

R3. The external console to program the subcutaneous device and to collect bioelectric data of the patient. It consists of a reader for wireless communication with the implanted device and a control software with an intuitive user interface. This will be handled by clinicians for programming the implantable device with the most appropriate stimulation protocol and follow-up treatment.

This way, most initial project aims have already been fulfilled, providing the consortium the valuable experience about the industrial and regulatory contexts of the final product, for its future commercial realization.

Prototypes were manufactured for being used in definitive animal experiments, according to the procedures authorized by the ethics committee. Animal experimentation allowed us to verify the functioning and operation of the integrated StimulAIS system. However, the animal experimentation has been troublingly tough. We could not see all envisaged results from the implanted devices to verify the full functionality of the device in-vivo (e.g. EMG measures for customized treatment), and some detected limitations have required complementary components development for being used with the animals, in order to get access to information or to improve in-situ usability.

 

Overall, the consortium’s aim for the next follow-on project is to produce a prototype validated industrially according to all the applying regulatory framework, for CE marking. Achieved in collaboration with specialized providers, this version of the product will participate in phase two and three clinical trials, in order to validate the device in humans. To achieve maximum impact, project promoter (Tequir) is leading the search for manufacturing and clinical partners who can upwardly scale production towards industrial volumes, and license StimulAIS technology – a prospect that is also an inviting business opportunity.

Further dissemination and exploitation activities are envisaged for consortium partners after project end, in order to facilitate and encourage the industrial and commercial exploitation of the results, while generating clinical evidence of StimulAIS system.

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Intermediate meeting on 21 May 2014, UPV Valencia

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Project Funded by EU Seventh Framework.

Students Love TechnologyThis project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under Grant Agreement No 315327