BIOMATERIAL COLLECTION

Transcription

1 BIOMATERIAL COLLECTION Innovation. Quality. Service. Value.

2 INDEX GRAFTING PAGE Allograft Bone Grafting DirectGen 1-2 Bone Grafting DirectGen Putty 3 Bone Grafting DirectGen FLEX 4 Synthetic Bone Grafting BioResorb Macro Pore 5 Soft Tissue Grafting DirectGen DERM 6 MEMBRANES Resorbable Kontour 7 CytoPlast RTM 8 Non-Resorbable CytoPlast TI250, TXT & GBR 9 SUTURES Resorbable Vilet 10 Non-Resorbable CytoPlast 11 Availability Not all products listed in this catalog are available in all countries. Please contact Implant Direct or your local dealer for more information on product availability.

3 DirectGen BONE GRAFTING-ALLOGRAFT DirectGen Allograft is a natural, safe and easy to use grafting material. This product comes in a variety of donated tissue types (cortical, cancellous or cortical-cancellous blend) and is suited for a wide range of clinical needs. DirectGen has been processed utilizing a proprietary process. This process allows for microbial inactivation while minimally manipulating the tissue. This process meets or exceeds requirements set forth by the FDA and American Association of Tissue Banks (AATB) and as a result, there have been no confirmed cases of disease transmission from allografts in its extensive history. Cancellous Particulate DirectGen Mineralized cancellous particulate has the interconnecting porosity associated with trabecular bone structure. This allows for increased capillary action of the blood which in turn promotes rapid formation of osteoblasts for new bone growth. Has increased porosity and surface area which promotes revascularization and supports in-growth of new bone. Cortical Particulate DirectGen Mineralized cortical particulate offers the structural strength and integrity associated with cortical bone. This results in a slower resorbing graft material that is ideal for space maintenance in grafting procedures. Provides longer lasting scaffold for new bone ingrowth Cortical-Cancellous Blend DirectGen Mineralized Blend is a 50:50 mixture of cortical and cancellous particulate. This pre-mixed, easy to use product is intended to provide the clinician with the features and benefits of both tissue types. Simplifies procedure by eliminating need to mix tissues chairside Single donor per vial Demineralized Cortical Particulate DirectGen Demineralized particulate has been processed to expose the bone morphogenic proteins within the bone matrix. This results in a graft material that has the potential to induce cell differentiation and new bone formation. Each lot is tested via BMP-2 assay POST sterilization DirectGen Mineralized/Demineralized Cortical Combo DirectGen Mineralized/Demineralized Cortical Combo is a 50:50 combination of mineralized cortical tissue and demineralized cortical tissue. This pre-mixed combination results in a material with osteoconductive properties as well as osteoinductive potential. Saves time and effort by eliminating need to mix tissues chairside Two different resorption rates for ideal space maintenance and exposure of bone morphogenic proteins earlier in the healing process 1

4 DirectGen Packaging Allograft: DirectGen Mineralized Cortical Item# ( μm) - 0.5cc DCOR $60 ( μm) - 1.0cc DCOR $80 ( μm) - 2.0cc DMCO $140 ( μm) - 0.5cc DMCO $60 ( μm) - 1.0cc DMCO $80 ( μm) - 2.0cc DMCO $140 Allograft: DirectGen Mineralized Cancellous Item# ( μm) - 0.5cc DCAN $80 ( μm) - 1.0cc DCAN $105 ( μm) - 2.0cc DCAN $170 ( μm) - 0.5cc DMCA $75 ( μm) - 1.0cc DMCA $100 ( μm) - 2.0cc DCAN $170 Allograft: DirectGen Mineralized Cortical/Cancellous blend Item# ( μm) - 0.5cc DBLN $80 ( μm) - 1.0cc DBLN $105 ( μm) - 2.0cc DBLN $170 Allograft: DirectGen Demineralized Cortical Item# ( μm) - 0.5cc ( μm) - 1.0cc ( μm) - 2.0cc DDCOR DDC DDCOR $60 $80 $170 Allograft: DirectGen Mineralized/ Demineralized Cortical Combo Item# ( μm) - 0.5cc DCMB $80 ( μm) - 1.0cc DCMB $105 ( μm) - 2.0cc DCMB $

5 DirectGen PUTTY BONE GRAFTING - PUTTY Innovation often follows the straightest path. In bone grafting, attention to basic fundamentals has always been the key to the best and most predictable clinical outcomes. Historically, bone itself is the best substrate for new bone formation. This is the philosophy behind DirectGen Putty, which is simply comprised of human bone and buffered water. DEMINERALIZED PUTTY Made from 100% human bone nothing added that may get in the way of bone healing Osteoconductive DBM provides an ideal scaffold that directs and supports bone formation Osteoinductive the osteoinductive potential of DBM is well established Excellent handling characteristics will shape and conform to fill unique bony voids, retains shape and resists wash-out, or migration, from graft site Easy to store and use stores at ambient room temperature, long three-year shelf life, and ready for immediate use; no prep time or reconstitution required Sterile gamma irradiated to SAL 10-6 Safe donor recovery and screening performed according to AATB and FDA guidelines Clinically versatile available in a flowable putty or as a flowable putty plus mineralized chips Available in two options and a variety of sizes: DirectGen Putty Size DP070 DP100 DP cc 1.0cc 2.5cc $135 $175 $350 DirectGen Putty PLUS Size DPP100 DPP cc 2.5cc $220 $

6 DirectGen FLEX BONE GRAFTING - ALLOGRAFT DEMINERALIZED CORTICAL ALLOGRAFT SHEET Proprietary processing leaves cortical sheet flexible which allows it to be easily adapted to act as missing wall in 3 wall defect or as an onlay to cover a graft site. Product retains enough rigidity to allow it to be easily tucked into periosteal envelope (as compared to a membrane) and maintains its position during flap closure and suturing. Rehydrates in minutes and can be easily shaped with scissors or scalpel. Can be tacked or sutured. Provides 3 dimensional osteoconductive scaffold that promotes revascularization and in-growth of new bone. Demineralization process exposes BMP-2 content native in the tissue. Each LOT is assayed and tested for its osteoinductive potential post sterilization. COMMON APPLICATIONS Repair of 3 wall defects Repair of access windows Ridge Augmentations DirectGen FLEX inserted subperiostelly to act as temporary wall 4 10mm x 10mm 10mm x 17mm 15mm x 15mm DFLX1010 (1/box) $100 DFLX1017 (1/box) $195 DFLX1515 (1/box) $215

7 BioResorb Macro Pore BONE GRAFTING-SYNTHETIC β-tricalcium PHOSPHATE BONE REGENERATION MATERIAL WITH ADVANCED POROSITY βioresorb Macro Pore is an osteoconductive, pure-phase β-tricalcium phosphate bone grafting material developed via a patented process that creates a porous structure most similar to human bone. The interconnecting micro & macro porous structure gives the advantage of allowing vascularization and cell transport into and throughout the particle, leading to new bone deposits within the particles themselves. βioresorb Macro Pore is made from 99% pure-phase Beta Tri-Calcium Phosphate (β-tcp). Each batch of product is tested via X-ray diffraction to ensure its purity. In addition, the calcium/phosphor atom ratio in βioresorb is 1.5 (very similar to the mineral phase of human bone which is 1.6). Histology at 7 months improved bone regeneration with a high activity of osteoblasts, homogenous cortical structures and no signs of inflammation. Odontogenic keratocyst 6 months after cyst removal and placement of βioresorb Macro Pore. Complete BioResborb Macro Pore restitution of bone structure. Item# Single pack (1 vial/1 box) μm 0.5ml $ μm 0.5ml $65 1.0ml $ μm 2.0ml 0.5ml 1.0ml $160 $65 $ ml $ μm 1.0ml $100 BioResborb Macro Pore 5- pack (5 vials/1 box) Item# μm 0.5ml μm 0.5ml ml μm 2.0ml 0.5ml 1.0ml $260 $260 $400 $640 $260 $

8 DirectGen DERM SOFT TISSUE GRAFTING - ALLOGRAFT DECELLURIZED DERMAL ALLOGRAFT TISSUE Biocompatible Retains collagen and elastin and has elasticity of the native dermis Processing preserves biologic properties that promote revascularization and repair of damaged tissues Eliminates morbidity and pain associated with a donor site Allows multiple sites to be treated in same surgery Proprietary processing allows either side to be placed against defect. No special orientation required Rehydrates in minutes and is easily trimmed with scalpel or scissors Retains enough firmness when hydrated to facilitate easy placement in graft site (especially when used for tunnel technique) Available in multiple thickness and size options: Thin ( mm) Size DD x10mm $80 DD x20mm $120 DD x40mm $190 DD x40mm $230 Thick ( mm) Size DD x10mm $80 DD x20mm $120 DD x40mm $190 DD x40mm $230 Pre-op DirectGen DERM trimmed for site Insertion of DirectGen DERM Site sutured 4 week post-op Case courtesy of Avi Schetritt, DMD 6

9 MEMBRANES

10 Kontour RESORBABLE MEMBRANE TYPE I PORCINE COLLAGEN RESORBABLE MEMBRANE Fully Resorbable; no second surgery required Easy to use; either side may be placed against defect. Can be used dry or hydrated. Hydrates in minutes. Membrane does not stick to itself when hydrated allowing for easy placement and/or repositioning Membrane retains sufficient memory when hydrated which allows it to be easily positioned under the periosteum uniformly without bunching up. This also allows the membrane to maintain its shape and position during closing, suturing and throughout its use Membrane is also soft and conformable. This allows membrane to adapt well to most varying bone topographies. Unique fiber orientation provides membrane with high tensile strength and high suture pullout resistance Provides effective barrier functionality for weeks COMMON APPLICATIONS Periodontal defects Sinus lift osteotomies Repair of access windows Soft tissue augmentation Periapical lesions 50X Magnification 15mm x 20mm KRM1520 (1/box) $ mm x 30mm KRM2030 (1/box) $115 30mm x 40mm KRM3040 (1/box) $

11 CytoPlast RTM RESORBABLE MEMBRANE TYPE I BOVINE COLLAGEN RESORBABLE TISSUE MATRIX Resorbable; eliminates second surgery Unique fiber orientation provides unusually high tensile strength Safe; manufactured from highly purified Type I bovine achilles tendon Layered construction allows cellular ingrowth of outer layer, but inner layers help prevent cellular and bacterial downgrowth Longer predictable resorption time of 26 to 38 weeks Guides healing of bone and surrounding tissue High mechanical strength for membrane stabilization using either sutures or resorbable tacks Excellent handling when wet, and either side can be placed against the defect Optimized flexibility and rigidity for better maintenance of space COMMON APPLICATIONS Periodontal defects Sinus lift osteotomies Repair of access windows Soft tissue augmentation Periapical lesions This cross sectional SEM view demonstrates the multi-layer construction allowing tissue integration in outer layer while preventing direct passage of bacteria and epithelial cells. CYTOPLAST RTM COLLAGEN 15mm x 20mm RTM1520 (2/box) $185 20mm x 30mm RTM2030 (2/box) $230 30mm x 40mm RTM3040 (2/box) $

12 CytoPlast TI250, TXT & GBR NON-RESORBABLE AND NON-RESORBABLE TITANIUM REINFORCED MEMBRANES THE ORIGINAL, PATENTED, HIGH-DENSITY PTFE MEMBRANE Non-resorbable; won t resorb prematurely leaving graft site exposed Made from d-ptfe; <0.3um pore size is impervious to bacteria Primary closure not required; less surgical time required. Soft tissue attaches but does not grow through membrane; allows for nonsurgical removal. Textured surface; increases membrane stabilization Titanium Insert (on TI250 membranes) provides membrane with shape memory and rigidity for superior space creation and maintenance while grafting CYTOPLAST TXT & GBR Cytoplast TXT2530 Cytoplast TXT mm x 30mm (4 membranes/box) $280 12mm x 24mm (10 membranes/box) $400 Cytoplast GBR2530 Cytoplast GBR mm x 30mm (4 membranes/box) $220 12mm x 24mm (10 membranes/box) $320 CYTOPLAST TI250 12mm x 24mm 14mm x 24mm Cytoplast Ti250 Anterior Narrow Cytoplast Ti250 Anterior Single Ti250ANL-1 (1 membrane/box) $110 Ti250ANL-2 (2 membranes/box) $200 Ti250AS-1 (1 membrane/box) $140 Ti250AS-2 (2 membranes/box) $250 Ideal for narrow single-tooth extraction sites, especially where one or more bony walls are missing. Ideal size and shape for single-tooth extraction sites, especially where one or more bony walls are missing. 25mm x 30mm 20mm x 25mm 17mm x 25mm Cytoplast Ti250 Posterior Large Cytoplast Ti250 Posterior Singles Cytoplast Ti250 Buccal Ti250PL-1 (1 membrane/box) $200 Ti250PL-2 (2 membranes/box) $365 Ti250PS-1 (1 membrane/box) $180 Ti250PS-2 (2 membranes/box) $325 Ti250BL-1 (1 membrane/box) $150 Ti250BL-2 (2 membranes/box) $270 Designed for grafting large bony defects, including ridge augmentation. Designed for grafting posterior extraction sites and limited ridge augmentation. Ideal for use in large buccal defects. The pilot holes create more secure membrane stabilization. 9 This SEM view shows the micro-machined textured surface, which increases the area available for cellular attachment by 250% without increasing porosity.

13 SUTURES

14 Vilet RESORBABLE SUTURES Vilet is a braided coated synthetic absorbable suture made from polyglactin (PGLA) CHARACTERISTICS Maintain approximately 75-85% of its original strength at two weeks and 50-65% of its original strength at 3 weeks post implantation. 1 Excellent knot security and tie down Superb handling Smooth Tissue Passage Reliable absorption profile Meets or exceeds the USP & EP requirements Resorbs completely in days Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box V Violet FS-2 V393U Undyed FS-2 V Violet FS-2 V392U Undyed FS-2 V386U Undyed C-3 V385U Undyed C-3 19mm 19mm 19mm 19mm 13mm 13mm 12 $60 12 $60 12 $60 12 $60 12 $90 12 $90 Vilet II Quick RESORBABLE SUTURES Is a fast-absorbing synthetic absorbable suture composed of a coated polyglactin (PGA). ADDITIONAL CHARACTERISTICS Maintain approximately 60-70% of its original strength after 1 week post implantation. 1 Completely resorbs in 42 days Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box VGQ Undyed C-3 VGQ Undyed FS-2 13mm 19mm 12 $ $70 1 Times are based on subcutaneous tissue implantation studies in rats. 10

15 CytoPlast NON-RESORBABLE SUTURES BENEFITS Non-resorbable, 100% Medical Grade d-ptfe Monofilament construction eliminates bacterial wicking Biologically inert & chemically non-reactive Not subject to weakening by tissue enzymes Excellent soft tissue response Soft; increased patient comfort Great handling, knot-tying & knot-holding characteristics COMMON APPLICATIONS Bone grafting procedures Guided tissue regeneration Implant surgery Periodontal surgery Ridge augmentation Soft tissue grafts Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box CS Undyed FS-2 19mm 12 $100 CS Undyed FS mm 12 $100 CS Undyed FS-2 19mm 12 $100 CS Undyed FS mm 12 $100 CS-06 PREM Undyed P-3 13mm 12 $120 CS-06 PERIO Undyed TP 1/2 Circle Taper Point 13mm 12 $100 1 Needle size smaller than typical FS-2 needle. 11

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