LAB 142 - Implants for Ligament & Tendon Reconstruction - Product Portfolio

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Text of LAB 142 - Implants for Ligament & Tendon Reconstruction - Product Portfolio

  • NeoligamentsA division of XirosSpringfield HouseWhitehouse LaneLeeds LS19 7UE UK

    Tel. +44(0)113 238 7202Fax. +44(0)113 238 7201enquiries@neoligaments.comwww.neoligaments.com

    Registered in England No.1664824

    Neoligaments, Xiros, Poly-Tape,Ortho-Tape MPFL System, Jewel ACL,Rota-Lok, AchilloCordPLUS and Fastlokare trademarks of Xiros.

    All rights reserved Neoligaments2010. Worldwide patents and patentspending.

    LAB 142 A

    The design and science behind why they work

    Implants forLigament & TendonReconstruction

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  • The Neoligaments product portfoliocomprises textile implants andfixation devices. The textile implantsfall into two types: general devicesand speciality devices.

    General devicesThe general devices are intended to be used for anysoft tissue approximation. They are available in a rangeof standard sizes, between 3 mm and 50 mm wide andin various lengths. They are available in two shapes: asingle thickness flat tape, or a double thickness (tube).Each of these may have an open or dense structure.The strength increases with width to improve theresistance to failure. The surgeon can select from thisrange the device best suited to the repair. Such devicesinclude the Poly-Tape and Ortho-Tape.

    Speciality devicesSpeciality devices are those which have been optimizedto repair a particular tissue. These include the Rota-Lok, for reconstruction of massive rotator cuff tears,and JewelACL, for anterior cruciate ligament (ACL)reconstruction. These devices typically include a mix ofspecific structural features such as sections of openand dense weave, pockets, or cords for pulling theimplant through bone tunnels. The dimensions, strength and stiffness characteristics of these devicesare biomechanically designed to suit their intendedapplication. This ensures the implant can withstand the load placed on it without failure and permits correct load transfer to encourage tissue ingrowth and remodelling.

    Textile Implants

    General Speciality

    Fixation Devices

    Product Portfolio

    Poly-Tape AchilloCordPlus Rota-Lok JewelACL FastLok

    Device: Fixation DeviceSize: 6 & 8 mmShape: N/AStructure: N/AFinish: N/AConstruction: Ti

    Device: Textile implantType: GeneralSize: 5 x 500 mm to

    50 x 800 mmShape: FlatStructure: OpenFinish: StandardConstruction: Weave

    Device: Textile implantType: SpecialitySize: 10 x 500 mmShape: FlatStructure: Open / DenseFinish: StandardConstruction: Weave

    Device: Textile implantType: SpecialitySize: 7 x 710 mmShape: Flat / TubeStructure: Open / DenseFinish: PlasmaConstruction: Weave

    Device: Textile implantType: SpecialitySize: 5 x 800 mmShape: Flat / TubeStructure: DenseFinish: StandardConstruction: Weave

    Ortho-Tape

    Device: Textile implantType: GeneralSize: 3 & 400/600 mmShape: FlatStructure: DenseFinish: StandardConstruction: Weave

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  • foot & Ankle Achilles tendon Peroneal tendon stabilization Lateral ankle ligament* Repairing fail foot*

    Knee Patellar tendon Quadriceps tendon Anterior cruciate ligament (ACL) Posterior cruciate ligament

    (PCL)* Medial patellofemoral ligament

    (MPFL) Tibial/femoral fixation of ACL/PCL

    grafts* Medial collateral ligament (MCL)* Lateral collateral ligament (LCL)* Popliteal tendon* Reattaching muscles to a tumour

    endoprosthesis*

    * Neoligaments has not clinically evaluated those procedures marked with an asterisk and does not currently supply a surgical technique manual for them. However, the use of the Poly-Tape for such procedures has been reported at conferences and in medical journals.

    Hip Iliofemoral ligament* Reattaching muscles to a tumour

    endoprosthesis*

    Shoulder Rotator cuff Acromioclavicular joint and

    coracoclavicular ligaments Antero-inferior gleno-humeral

    ligament capsular reinforcement Augmented subscapularis

    muscle transposition for rotator cuff repair during shoulder arthroplasty*

    The Neoligaments product portfolio is versatileand surgeons have used these implants for repairor reconstruction of many ligaments and tendonsin the joints of both the lower and upper limbs.

    Applications

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  • Textile implants offermany benefitsThe factors that made textile implants soappealing when they were first introducedremain as relevant and valid as ever. Theiruse for ligament and tendon reconstructionoffers the following benefits:

    they remove the need for harvesting autologous tissues and so eliminate the pain, muscle deficiency and donor site morbidity associated with the harvesting procedure;

    where they are used instead of allografts, the risk of cross infection is eliminated;

    their use shortens the surgical procedure by the time consumed in graft harvesting and/or preparation;

    textile implants offer consistency as they have uniform properties and dimensions whereas tissue grafts vary in both properties and dimensions;

    textile implants retain their initial strength, which is sufficient to permit earlier weight bearing and earlier return to activities than do tissue grafts because of the debilitating necrotic stage they go through, when they loose much of their strength that is recovered over a long period postoperatively;

    because textile implants are readily available in abundance they facilitate complex reconstruction procedures where a recipient has sustained multiple injuries to ligaments in one joint.

    Manufactured frompolyester, a materialwith many years ofimplant historyThe Neoligaments textile implants aremanufactured in-house, at dedicatedmanufacturing sites in the UK, frompolyethylene terephthalate (PET) which iscommonly know as polyester. Polyester hasmechanical properties which, with carefuldesign, can match the strength and stiffnessof natural tissue. It is therefore ideal for themanufacture of implants for ligaments and tendons.

    This nonabsorbable material is one of themost common polymers to be used inmedical implants. For more than 40 yearsit has been utilized in the manufacture ofarterial grafts and aortic implants. It hasbeen used for fixation of ACL grafts(EndoButton Continuous Loop, Smith & Nephew) for over 10 years, for ligaments for over 25 years and for sutures for over 70 years.

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  • 3000

    2000

    1000

    0 ACLNative tissue

    Strength (N)

    ESP3000Leeds-Keio

    The implants possesshigh strength so canallow early rehabilitationThe textile implants have been thoroughly testedto determine their initial strength and stiffnesscharacteristics and their response to simulatedexercise. As an example, the NeoligamentsESP3000 ACL ligament which is used for youngactive patients, has undergone cyclic testingequivalent to both one and six years of simulatedexercise from implantation. The resultsdemonstrate that the implant can withstand theloads placed on it without failure. It also indicatesthat the stiffness is similar to that of the naturalACL so permits correct load transfer toencourage cell growth.

    4000

    Stiffness (N/mm)

    The structure provides a scaffold for tissueingrowthNeoligaments textile implants are predominantlyof woven construction, comprising parallellongitudinal (warps) and transverse (weft) fibreswhich cross at right angles. The implantstypically possess an open structure that actsas a scaffold allowing bone and tissue ingrowth.This new tissue protects the device fromabrasion and, as it matures, it providesadditional strength. This scaffold implant is notto be confused with the permanent typeimplant, such as the Gore-Tex device, which isdesigned to last a lifetime with no contributionfrom the host tissue or new tissue growth.

    All our implants arebiologically safeThe process of manufacturing ensures thatthe implants are free from contaminantsbefore they are supplied, sterile with gammairradiation, in sealed double blister or pouchpackages. The intended shelf life of theproduct has been validated.

    The products have been thoroughlyevaluated for biological safety using a rangeof tests following ISO 10993-1 Biologicalevaluation of medical devices Part 1:Evaluation and testing within a riskmanagement process. A quarter of acentury of extensive clinical use withextremely low levels of reported problems is evidence of the outstanding safety of the products.

    Our unique plasmatreatment processspeeds cell growthSelected textile implants are subjected to a proprietary low-power cold gas plasmatreatment process. This forms oxidized chemical groups on the material surface, turning the standard hydrophobic polyester into a hydrophilic material.

    This has a dramatic effect, increasing the speedand extent of cell recruitment and theiradherence to the implant. In vitro studies havefound that tissue ingrowth is approximately fourtimes faster [Rowland et al. 2003; Tsukazaki etal. 2003]. Prompt tissue growth has also beennoted clinically via postoperative arthroscopy,biopsy and transmission electron microscopestudies on scaffold textile implants used for ACLreconstructions [Sugihara et al. 2006].

    Scanning electron microscopy (SEM) showing portions ofcontrol (left) and plasma treated (right) polyester scaffoldsfive days after incubation. Note the greater coverage of thetreated materials by synovial stromal cells.

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  • Both pre-clinical andclinical studies haveconfirmed that theNeoligaments openstructure provides ascaffold for tissueingrowth

    Pre-clinical studiesNumerous studies have reported on

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