Stimulais Project > stimulais

The final consortium meeting of StimulAIS project has been arranged by TEQUIR (Project Coordinator). This meeting will take place in Valencia, Spain, on Tuesday 10th March 2015.

All consortium partners will be represented in the meeting and will have the opportunity to discuss about the work progress carried out in the last stage, as well as to share the results achieved, according to the expected milestones.

Dr. Barrios (clinical expert from UCV) has actively participated in the following three conferences in the medical sector, disseminating StimulAIS project to specialized research audience :

• GEER XXVII
• 8th World Combined Meeting of Orthopaedic Research Societies
• INVESCOT X

* XXVII GEER Congress

Conference: “Coordinación de la musculatura paraespinal superficial y rotadora profunda en la Escoliosis Idiopática. Estudio electromiográfico intramuscular en diferentes movimientos del raquis”. Sociedad de Estudios de Enfermedades del Raquis (GEER).

Valencia, 30 Mayo-1 Junio 2013.

* 8th World Combined Meeting of Orthopaedic Research Societies

Conference: “Myoelectric imbalance in the coupled activity of the superficial long paraspinal muscles and the deep rotators at both sides of the curve in patients with idiopathic scoliosis. Direct intramuscular recording in different spine tasks”

Venice (Italy), 13-16 October 2013

* INVESCOT X

Conference: “Asociación Española de Investigación en Cirugía Ortopédica INVESCOT X Asimetrías en la actividad mioeléctrica de la musculatura torácica paraespinal superficial y rotadora profunda en la Escoliosis Idiopática. Estudio electromiográfico intramuscular en diferentes movimientos del raquis”

More than fifty Researchers Attended the X INVESCOT 2014 National Conference of the Spanish Association for Research in Orthopaedic Surgery and Traumatolgía held at the Medical Surgical Hospital in Santiago de Compostela Conxo.

In addition, an ABSTRACT has been submitted to "Bone & Joint Journal Orthopaedic Proceedings Supplement (2014 vol.96-B no. SUPP 11 58)".

This is a clear evidence of the dissemination that Dr. Barrios is making the StimulAIS system in scientific journals with worldwide impact.

Publication access link:

http://www.bjjprocs.boneandjoint.org.uk/content/96-B/SUPP_11/58.abstract

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.

As part of the Dissemination Plan, Fraunhofer-IPMS has participated with a trade-show booth at MEDICA fair, celebrated in Dusseldorf (12-15 November 2014), for presentation of the StimulAIS active implantable device.

Dr. Eng. Andreas Heinig (from IPMS) has presented the StimulAIS active implantable device, and attended target stakeholders in the medical sector about its application and functionalities.

Furthermore, he has shown and delivered brochures with the StimulAIS dissemination article, published by the consortium (http://stimulais.com/comunidad/stimulaisproject/recurso/stimulais-dissemination-article-noninvasive-treatm/10f3b218-e252-42c8-91dc-34e776d5d114), in order to raise awareness and wider dissemination of project results.

Some pictures from MEDICA fair are attached:

CORDIS is the primary repository and website for EU-funded projects and results.

The current StimulAIS report summary expones:

   - Project Context and Objectives

   - Project Results

   - Potential impact and wider benefits for Europe

This is published and linked to StimulAIS project's permanent factsheet at: http://cordis.europa.eu/project/rcn/105659_en.html

The intermediate meeting of StimulAIS project has been arranged by UCV. This meeting will take place in Valencia, Spain, on Tuesday 26th November 2013.

All consortium partners will be represented in the meeting and will have the opportunity to share the state of the results achieved so far, as well as discuss about the work progress, next tasks and expected results (integration and validation of StimulAIS system), giving rise to the most critical issues for a successful consecution of the next milestones.

AGENDA INTERMEDIATE MEETING

Project StimulAIS

Date:     Tuesday, November 26^th 2013

Place     UCV (San Carlos Borromeo complex)

Address: C/ Quevedo, 2. First floor.

46001 - Valencia

SPAIN

End of Intermediate Meeting

The Six-Months Meeting of the StimulAIS project took place last 16th April 2013 at Fraunhofer Institute for Photonic Microsystems IPMS, in Dresden, Germany.

The results of the deliverables of the first work package were presented to the Consortium, and the members clarified some questions that are important for the next stages. The next technical steps of the project were established, and also this webpage was introduced to the partners.

At the moment, the Consortium has reached the main objectives of the project planned for this period, such as the study of software and hardware feasibility, or the definition of the main stimulation parameters that the system will require. The results obtained during this period have allowed the partners to start working in the next work packages, where the Consortium expects to obtain the first prototypes of the system.

In parallel, the whole Consortium is involved in the definition of the main risks to which the system has to deal with, taking into account European applicable standards.

Consortium members arranged next technical meetings that will take place by videoconference in the next months.This is a picture of the StimulAIS team members that attended this meeting.

The partners of the StimulAIS project have arranged the Six-Months Consortium Meeting. This meeting will take place in Fraunhofer-IPMS facilities, in Dresden, Germany, on Tuesday 16th April 2013.

All the partners will be represented in the meeting and will have the opportunity to better know the state of the project and to plan next technical work.

In addition, this webpage will be introduced to the Consortium members.

Instituto de Biomecánica (Biomechanics Institute - IBV) hosted the kick-off meeting of the European project       Stimu    lAIS       on 28th November 2012.  

The main objective of the   StimulAIS   project is to develop a novel device for the treatment of adolescent idiopathic scoliosis by muscular electro-stimulation of the appropriate muscles. This device will be capable not only of stopping progression of the curvature, but also of correcting it. It will represent a strong differentiation in AIS treatment, as it will avoid the side effects of the current conservative solutions and will reduce the need of invasive fusion surgery.

Nowadays, current treatment options have important limitations. Conventional treatment like bracing is uncomfortable and stressful and there is no clear evidence of its effectiveness in stopping progression of spine curvature; surgery halts progression, but fuses the spine, eliminating its mobility.

The first technical steps of the project were established, and also financial information of the project was introduced to the partners. Consortium members highlighted the importance of comunication between the partners to obtain good results during the project.

The     StimulAIS     project effectively started on 1st November 2012.

This is a picture of the     StimulAIS     team.

Six partners are participating in the     StimulAIS     research project. TEQUIR S.L., from Spain, is the Project Coordinator.

The research will be undertaken by the RTDs (Instituto de Biomecánica de Valencia, Universidad Católica de Valencia and Fraunhofer-IPMS) by a core group of SMEs (Tequir, Synimed and Bentronic ), who will provide the initial supply chain. These partners have been specifically brought together to provide the necessary blend of skills and expertise and with the common focused aim of developing an innovative and minimally invasive technology that can prevent progression of idiopathic scoliosis.

Three European countries participate in the project: Spain (1 SME+2 RTDs), Germany (1 SME+1 RTD) and France (1 SME).

SMEs

TEQUIR S.L.

Polígono Industrial El Oliveral, C/C, s/n

CP. 46190 Ribarroja del Turia (Valencia) SPAIN

Contact persons: Álvaro Alonso, Magdalena Bresó

Email: alvaroalonso@tequir.com

Email: magdabreso@tequir.com 

Web: www.tequir.com

SYNIMED

Z.A. DE L’ANGLE, 19370, Chamberet, France

Contact person: Carlos Paez

Email: carlos.paez@synimed.com

Contact person: Cosme Argerich

Email: cargerich@laboratoriossl.com

Web: http://www.synimed.com/

BENTRONIC

Hagertshausen, 7, 85283, Wolnzach, Germany

Contact person: Matthias Boeck

Email: matthias.boeck@ast.de

Contact person: Wolfgang Zwack

Email: wolfgang.zwack@ast.de

Web: http://www.bentronic.com/

RTDs

INSTITUTO DE BIOMECÁNICA DE VALENCIA

Universidad Politécnica de Valencia, Edificio 9C, Camino de Vera s/n, 46022, Valencia, Spain

Contact person: Joaquín López

Email: joaquin.lopez@ibv.upv.es

Web: http://www.ibv.org/en

UNIVERSIDAD CATÓLICA DE VALENCIA

Plaza S. Agustín, 3, esc. A entresuelo 1, 46002 Valencia (SPAIN)

Contact person: Carlos Barrios

Email: carlos.barrios@ucv.es

Web: https://www.ucv.es/

FRAUNHOFER-IPMS

Maria-Reiche-Str. 2 - 01109 Dresden (GERMANY)

Contact person: Andreas Heinig

Email: andreas.heinig@ipms.fraunhofer.de

Web: http://www.ipms.fraunhofer.de/