Project: Research and Development of a Textile-Based Annulus Repair Device

The goal of this project is to launch a new medical implant on the market; the new device will combine high-tech medical textile and a special bone anchorage to treat patients suffering from lumbar disc herniation._x000D__x000D_Lumbar disc herniation is one of the CO causes for low back pain. A lumbar disc is made up of a nucleus pulposus surrounded by an annulus fibrosus. A hernia occurs when the annulus bursts and the nucleus leaks out of the disc. Between 49% and 80% of the population suffers an episode of back pain at some point in their lives [1].The high socio-economic impact of this disease has led to great efforts and investments by governments and private enterprise, but low back pain reCOs one of the greatest challenges of the medical industry._x000D_The most frequent surgical procedure to treat intervertebral disc herniation is a discectomy: cutting through the ruptured annulus fibrosus and removing the herniated nucleus. After the intervention, the annulotomy (hole in the annulus resulting from the resection) is left open. Discectomy initially results in an improvement in low back pain and mobility, but recurrent disc herniation (re-herniation) occurs in over 10.2 % of patients, and 26% lose disc height. This usually leads to surgical revisions, and an acceleration of the intervertebral disc degeneration process. There is evidence that proves that disc re-herniation increases with the size of the annular defect, and intervertebral disc height loss depends on the percentage of disc volume removed [2]._x000D_ Annulus repair (AR) is a promising technology aimed at sealing the annulotomy created during a discectomy. The AR device market is a very young but promising market since it would be a long-term solution to lumbar disc herniation and consequently low back pain. The AR market is part of the multi-billion dollar global Spinal Surgery Market: European Market in 2010 estimated at 470 million$, US market in 2009 estimated at 2.9 billion$ [3,4]._x000D_The Ar-Tex project will launch a new annulus repair device on the market. This new device will have the following advantages: _x000D_- Robust resistance to nucleus reherniation without risk of subsidence into vertebral bodies, _x000D_- Perfect fit to individual annulutomy sizes for a reliable performance _x000D_-Robust anchorage in intervertebral space to avoid extrusion into posterior vertebral space, and ensure correct implant functionality_x000D_In order to attain the challenging requirements of the final product, the Ar-Tex project will include the following research activities:_x000D_- Textile materials selection for the annulus repair device taking into account biocompatibility, mechanical properties (high strain, high strength), and processability._x000D_- Textile structure processing, and tailoring to obtain: anisotropic mechanical properties, controlled permeability, and reinforcement of the textile for dimensional and anchorage stability._x000D_- Design and development of the annulus repair device, its anchorage and the instrumentation for insertion_x000D_- The characterisation and validation of the structures and designs: in vitro, in cadaver and in vivo_x000D__x000D_In addition, the Ar-Tex project will pay special attention to scale-up issues, market issues, regulatory and patent monitoring in order to devise a swift certification, IPR and market launch strategy. _x000D_The Ar-Tex consortium is made up of two Spanish SMEs; Neos Surgery S.L. (NEOS), and Calvo Izquierdo S.L. (CALVO), and one German Technological Centre: Institut für Textil- und Verfahrenstechnik Denkendorf (ITV). NEOS is a high-tech SME which develops and commercialises implants for neurosurgical applications. CALVO is a textile SME, specialised in the production of wound dressings, surgical dressings and technical textiles. ITV is Europe’s largest textile technological centre. Its goal is to convey scientific results on textile technology and processing to the industry, and conducts research along the whole production chain in close cooperation with international networks. _x000D_NEOS has developed the preliminary implant design, and has compiled its mechanical and biological requirements. NEOS has also researched the market and patent environment for Annulus Repair devices. NEOS will coordinate the project, design the final implant and its instrumentation and work on the regulatory aspects of the implant launch. CALVO and ITV will work on the textile technology aspects of the project: material and processing selection, post-processing and mechanical characterisation, as well as certification. They have also researched the market and patents concerned with implantable textile processing, tailoring and packaging. _x000D_1. PAIN, 2000, vol 84, pp 95_x000D_2. SPINE, 2009, vol 34, pp 2044_x000D_3. Medtech-insight, 2006, “European Markets for Spinal Fusion Products” Report #A306_x000D_4. Frost&Sullivan “US Spinal Surgery Market N740-54”, 2010_x000D_

Acronym Ar-Tex (Reference Number: 5999)
Duration 01/01/2011 - 31/08/2014
Project Topic Research and Development of an Annular Repair Device based on innnovative implantable textiles. The project includes research on: textile material and structure , device fixation, instrumentation and preliminary biocompatibility and biomechanical evaluation.
Project Results
(after finalisation)
The CO result of the project P DITF was the successful development of the textile part of the Annulus Repair Device (for details see reports of the P NEOS). The development was achieved in close co-operation with the other Ps of the project. The development phase was completed and the final design was verified.
Network Eurostars
Call Eurostars Cut-Off 5

Project partner

Number Name Role Country
3 Deutsche Institute fuer Textil- u.Faserforschung, Institut f.Textil- u.Verfahrenstechnik Partner Germany
3 NEOS SURGERY SL Coordinator Spain
3 CALVO IZQUIERDO S.L. Partner Spain