Dural Repair DURAL REPAIR. Solutions

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Transcription:

Durl Repir DURAL REPAIR Solutions

Science Technology Innotion Proen Performnce Six Pltform Technologies At Collgen Mtrix we re pssionte bout dncing the science of tissue repir nd We he deeloped six proprietry tissue regenertion. Tht s why we re the driing force engineering technologies to expnd our brod line in the design, deelopment nd mnufcturing of of collgen nd minerl bsed medicl deice dnced collgen nd minerl bsed medicl solutions. deices tht support the body s nturl bility to regenerte. T1 Reconstituted Collgen T2 Intct Collgen Oer our 20 yers of proen performnce, we he T3 Nturl Crbonte Aptite Minerl focused our proprietry technologies nd innotie T4 Collgen nd Minerl Composites products to meet clinicl needs through fie key T5 Collgen Cotings business units Dentl, Spine, Orthopedic, T6 Crosslinking Durl Repir nd Nere Repir. Du trix-on M l r y rmtrix Du Beginn i the ng In Eolution of DurMtrix Products 1997 2005 2008 Dur trix-only M s Plu le b Dur trix Sutu r M 2015 2016 Nere epir Durl epir Spine Dur l Repir CollgenM t r ix.com 15 Thor nt on Ro d O k l nd, N J 07436, U SA 201.405.1477 Durl Repir P g e 2

Why Use Durl Repir Substitute? When the dur mter tht encses the brin nd spinl cord is dmged or impired, it risks cerebrospinl fluid (CSF) lekge, which cn cuse serious complictions to the ptient. A durl repir substitute proides scffold for host dur to regenerte. 7.5 million Our products he helped ptients worldwide with oer 7.5 million medicl deices tht he been produced cross ll fie key business units. Innotie Solutions We he engineered collgen durl repir products tht re CSF lek resistnt nd which he collgen scffold properties tht llow for ntie durl tissue to nturlly regenerte resulting in the protection, closure nd repir of durl defects. DurMtrix Portfolio of Collgen Durl Repir Products Boine Suture Sterile Collgen Pull Out Lek Resorption Sline Durl Repir Product Source Conformbility Strength 5 Resistnt 4,5 Time 3,4 Hydrtion DurMtrix-Only Plus Achilles Completely Low 1 Yes 8 weeks Prior to use Tendon DurMtrix Suturble Intct Modertely Very High Yes 9 months 1 minute Dermis DurMtrix-Only Achilles Highly Modertely 2 Yes 6-9 months 30 seconds Tendon DurMtrix Achilles Modertely High Yes 6-9 months 5 minutes Tendon Pge 3 Durl Repir CollgenMtrix.com 15 Thornton Rod Oklnd, NJ 07436, USA 201.405.1477

DurMtrix-Only Plus COLLAGEN DURAL REGENERATION MATRIX A sponge-like only with lek resistnt top lyer mtrix is esily repositionble nd conforms to the complex surfces of the brin or spinl cord. The completely resorbble mtrix does not dhere to surgicl instruments or gloes. Lek resistnt top lyer Proprietry collgen coting technology Film on top surfce lso improes wet hndling chrcteristics Spo Porous sponge bottom lyer Proides drpebility, only ppliction n g e lyer nd resists sidewys moement Conforms to brin contours Scnning Electron Microgrph of mtrix cross section t 50x mgnifiction 50x more lek resistnt thn DurGen Plus in liquid permebility test Spine 4,5 ginst CSF n le tio ge k Pro tec Nere epir Durl epir Sm lekge. When hydrted, this highly drpeble r ye tht proides effectie protection ginst CSF k resistnt to e l p th, l o o Scn here to iew lekge test ideo Dur l Repir CollgenM t r ix.com 15 Thor nt on Ro d O k l nd, N J 07436, U SA 201.405.1477 Durl Repir P g e 4

DurMtrix Suturble COLLAGEN DURA MEMBRANE This suturble membrne is deried from intct boine dermis. The nturl collgen fibers re then biochemiclly reinforced through proprietry crosslinking process to proide high mechnicl strength nd CSF lek resistnce. Nerly twice the suture pull out strength s Durepir 4,5 Densely pcked collgen fibers Mechniclly strong, yet conformble Almost double the resorption time s Durepir 4,5 DurMtrix Suturble stys long enough to ct s scffold to llow new dur to regenerte. Scn here to o iew high suture pull out strength ideo SUTURE PULL OUT STRENGTH Newtons 25 20 15 10 5 0 20 Newtons DurMtrix Suturble Nerly TWICE the Strength 11 Newtons Durepir DurMtrix Suturble shows significntly higher suture pull out strength, nerly twice the strength when compred to Durepir. 4,5 Almost DOUBLE the Resorption Time DurMtrix Suturble hs resorption time of bout 38-40 weeks compred to 20-22 weeks for Durepir in rbbit durplsty study. 3,4 Blnced resorption llows for optiml time for tissue regenertion. RESORPTION PROFILE DurMtrix Suturble Durepir 22 Weeks 40 Weeks 0 5 10 15 20 25 30 35 40 45 Weeks Pge 5 Durl Repir CollgenMtrix.com 15 Thornton Rod Oklnd, NJ 07436, USA 201.405.1477

DurMtrix-Only COLLAGEN DURA MEMBRANE f Conforms to defect site Confo f rms to defe ct site DurMtrix-Only is thinner lterntie to DurMtrix-Only Plus nd cn be implnted without sutures. This only conforms to the contours of the brin or spinl cord creting CSF lek resistnt membrne nd is completely resorbble. Highly conformble Conforms closely to the complex surfces of the exposed brin or spinl cord Only ppliction Designed for implnttion without sutures chrcteristics hndling Excellent Only 30 Seconds of Hydrtion Time Highly Conformble Durl Repir CollgenMtrix.com 15 Thornton Rod Oklnd, NJ 07436, USA 201.405.1477 Pge 6

DurMtrix COLLAGEN DURA MEMBRANE Our originl durl repir membrne ws designed to optimize conformbility nd strength. It hs thickness similr to ntie dur nd cn be pplied s n only or suturble membrne. It hs n effectie blnced resorption nd tissue replcement resorption profile. Flexible, yet strong Conforms to defects Verstile ppliction Implntble with or without sutures More BALANCED RESORPTION thn DurGen DurMtrix hs resorption time of bout 26-38 weeks compred to <12 weeks for DurGen in rbbit durplsty study. 4,6 DurMtrix ws specificlly designed to resorb t blnced rte tht gies the ntie tissue sufficient time to regenerte. 100 DurMtrix 100 DurGen 80 80 Stedy regenertion Fst resorption % Implnt remining 60 40 Slow resorption % Implnt remining 60 40 Limited regenertion 20 20 0 0 0 5 10 15 20 25 30 35 40 0 5 10 15 20 25 30 35 40 Weeks Weeks Pge 7 Durl Repir CollgenMtrix.com 15 Thornton Rod Oklnd, NJ 07436, USA 201.405.1477

DurMtrix-Only Plus DurMtrix Suturble DurMtrix-Only DurMtrix Ctlog No. Dimensions Ctlog No. Dimensions Ctlog No. Dimensions Ctlog No. Dimensions DMOP11 (2.5 x 2.5 cm) DMS11 (2.5 x 2.5 cm) CDSLM11 (2.5 x 2.5 cm) CDSM11 (2.5 x 2.5 cm) DMOP13 (2.5 x 7.5 cm) DMS13 (2.5 x 7.5 cm) CDSLM13 (2.5 x 7.5 cm) CDSM13 (2.5 x 7.5 cm) DMOP22 (5 x 5 cm) DMS22 (5 x 5 cm) CDSLM22 (5 x 5 cm) CDSM22 (5 x 5 cm) DMOP33 (7.5 x 7.5 cm) DMS33 (7.5 x 7.5 cm) CDSLM33 (7.5 x 7.5 cm) CDSM33 (7.5 x 7.5 cm) DMOP45 (10 x 12.5 cm) DMS45 (10 x 12.5 cm) CDSLM45 (10 x 12.5 cm) CDSM45 (10 x 12.5 cm) DMOP57 5 x 7 in (12.5 x 17.5 cm) CDSLM57 5 x 7 in (12.5 x 17.5 cm) 5 x 7 in 12.5 x 17.5 cm 10 x 12.5 cm 5 x 5 cm 2.5 x 7.5 cm 2.5 x 2.5 cm 7.5 x 7.5 cm References: 1. Indicted for only ppliction; Suturing is not required, but tensionless, trumtic sty sutures my be used if desired. 2. Indicted for only ppliction; Suturing is not required, but if desired, miniml tension sutures my be used. 3. Rbbit durplsty study: Dt on file t Collgen Mtrix, Inc. 4. The results of pre-clinicl nd in itro studies my not be indictie of humn clinicl outcomes. 5. In itro dt on file t Collgen Mtrix, Inc. 6. Ulreich JB, French MH, Fryburg K, White, MJN, Ho, WY, Hmilton AJ. DurMtrix, A Noel Collgen Dur Substitute: Comprison with DurGen nd Dur-Gurd. Society for Biomterils 30th Annul Meeting Trnsctions. p.147, 2004. DurMtrix-Only nd DurMtrix re registered trdemrks of Collgen Mtrix, Inc. DurMtrix-Only Plus, DurMtrix Suturble, DurMtrix-Only nd DurMtrix re mnufctured by Collgen Mtrix, Inc., Oklnd, New Jersey USA. DurGen is registered trdemrk of Integr Lifesciences Corportion. Durepir is registered trdemrk of TEI Biosciences Inc. Not ll products shown or described in this literture re ilble in ll countries. MS597 Re. 1 CollgenMtrix.com 15 Thornton Rod Oklnd, NJ 07436, USA 201-405-1477