Citagenix Catalogue 2017 ALLOGRAFTS BONE SUBSTITUTES BONE GRANULES & BLOCKS RESORBABLE MEMBRANES

Transcription

1 Citagenix Catalogue 2017 ALLOGRAFTS BONE SUBSTITUTES BONE GRANULES & BLOCKS RESORBABLE MEMBRANES

2 100% Allograft Hydratable Inductive Matrix NEW Create your customized osteoinductive graft by combining PentOS OI Max, a 100% allograft Inductive Collagen Matrix (ICM) with your choice of blood, BMA, PRP, I-PRF or simply saline to form a moldable graft which is cell friendly, independent laboratory in vitro studies show to be able to maintain between 96% and 116% cell viability after 72 hours. PENTOS OI Max is an osteoinductive matrix - not diluted by any carriers. FEATURES AND BENEFITS Mixed graft can be extruded through a syringe Demonstrated Osteoinductivity - up to 40x native BMP vs the BMP-2 control - each lot histologically demonstrates all 5 elements of bone formation Demonstrated Osteoconductivity ph balanced non cytotoxic Shown to form bone post-sterilization in-vivo Resists copious irrigation 5 year shelf life at ambient storage PentOS OI Max can resist copious irrigation Available jar sizes: 1cc and 2.5cc Create your own osteoinductive graft Mixed with saline or blood concentrate Can be extruded through a syringe CitagenixUSA.com PentOS-OI.com

3 CONTENTS 2017 MEMBRANES BONE GRAFTS PENTOS OI Proven to form bone Page 6 C-GRAFT PUTTY & C-BLAST PUTTY Demineralized Bone Matrix Page 7 RAPTOS Allograft bone particulates and bone blocks Page 8 ECLIPSE Synthetic resorbable bone substitute Page 9 10 NEOMEM Resorbable Bovine Collagen Membrane Page 11 NEOMEM FLEXPLUS Resorbable Porcine Collagen Membrane Page 12 NEODERM Natural elasticity of human acellular dermis Page 13 4 new product WOUND DRESSINGS 14 NEOPLUG Cylindrical shape adapts easily to surgical sites Page 14 NEOCOTE Thicker sponge shape protects soft tissue Page 14 NEOTAPE Thinner tape like design for more intricate uses Page info@citagenix.com CitagenixUSA.com 3

4 Visit our website at CitagenixUSA.com ICM Versatile Grafting Solutions DBM DBM Regenerative properties Description PentOS OI Max 100% Allograft Inductive Collagen Matrix (ICM) Create your customized osteoinductive graft by combining PentOS OI Max with your choice of blood, blood cell concentrate or simply saline to form a moldable graft which can be extruded though a syringe. PentOS OI Max is an osteoinductive matrix - not diluted by any carriers. PentOS OI Putty PentOS OI Putty is made from 100% human bone without any additional diluent or carriers to diminish its osteoinductive properties. EVERY lot used to manufacture PentOS OI products is verified to be osteoinductive and histologically demonstrates all five elements of bone formation. C-Graft Putty Demineralized Bone Matrix in CMC - a natural, plant derived, carrier for superior handling. C-Blast Putty A composite graft product that combines osteoinductive DBM and osteoconductive cancellous particles in CMC. Characteristics Osteoinductive - up to 40x native BMP vs the BMP-2 control - each lot histologically demonstrates all 5 elements of bone formation Osteoconductive Cell friendly over 96% cell viability ph balanced non cytotoxic Shown to form bone post-sterilization in-vivo Resists copious irrigation 100% allograft - no additional carrier 100% bone Verified to be osteoinductive Osteoconductive Excellent handling characteristics Resists irrigation Sterilized using low-dose gamma irradiation Ready to use Stored at room temperature No inert carrier up to 19x native BMP vs the BMP-2 control C-Graft Putty: DBM with natural CMC carrier Excellent handling Great pricing Ready to use Open bore syringe C-Blast Putty: Demineralized Bone Matrix (DBM) with Cancellous Bone and CMC carrier Osteoinductive and osteoconductive Applications An osteoinductive base for composite graft preparation Bone defects and sites requiring a high level of osteoinduction Periodontal defects Implant site development Coronal defects around immediate implants Extraction site repair Implant dehiscence defects Sinus lift procedures Moderate localized ridge defects Periodontal defects Implant site development Coronal defects around immediate implants Extraction site repair Implant dehiscence defects Sinus lift procedures Moderate localized ridge defects Mixing options May be hydrated with saline, blood, BMA, PRP or other biological preparations as the clinician deems appropriate. May be used alone or mixed with Raptos allograft bone and/or Eclipse synthetic bone. May be used alone or mixed with Raptos allograft bone and/or Eclipse synthetic bone. Availability Available jar sizes: 1cc and 2.5cc Putty in a syringe. 0.5 cc, 1 cc, 2.5 cc and 5 cc Putty in a syringe. 0.3 cc, 0.5 cc, 1 cc and 3 cc DBM Demineralized Bone Matrix ICM Inductive Collagen Matrix

5 Versatile Grafting Solutions ALLOGRAFT ALLOGRAFT SYNTHETIC Regenerative properties Raptos Allograft Cancellous, cortical, cortico-cancellous and demineralized irradiated bone particulates that offer an osteoconductive scaffold for bone regeneration. Premium Blend This cortical mineralized/demineralized (70/30) blend combines two of the most popular allograft particles used in dentistry, all in a single syringe! PentOS OI Flex Demineralized, osteoinductive 100% cortical bone veneer graft. When hydrated, the veneer graft becomes pliable and easily adapts to graft sites that would be difficult to treat with particulate or putty grafts. Eclipse Synthetic resorbable bone substitute that uses the mineral building blocks naturally found in human bone. Granules: 80%ß-tcp - 20%HA Putty: HA + ß-tcp + Hydrogel Description Osteoconductive scaffold Remodels completely to host bone Mineralized graft material Osteoinductive demineralized Cortical veneer 1 mm thick Can be fixated with screws, tacks and sutures Freeze-dried Sterilized using low-dose gamma irradiation Has a shelf-life of 5 years from the date of sterilization Macro and Micro pores allow complete remodeling Completely remodels to host bone while preserving volume (12-18 months*) * Resorption and bone regeneration times are estimates as each patient and case is unique. Characteristics Mineralized component in a composite graft As a graft extender Osseous defects Onlay grafting for the repair of shallow bone defects or bone loss To augment thin or missing bone over root form implants Orbital floor repair Cases where it is difficult to place particulate grafts Ridge preservation Extraction site repair Sinus lift procedures Ridge augmentation Osseous defects Periodontal defects Applications May be used alone or mixed with DBM Putty for osteoinductive potential. May be used alone or in combination with other graft materials. May be used alone or mixed with DBM Putty for osteoinductive potential. Mixing options Available in syringes in a variety of sizes. Available in these sizes: 10x10 mm, 15x15 mm and 17x10 mm Granules available in vials or syringes. Putty available in syringes. Availability CMC Carboxymethylcellulose carrier 5

6 100% Bone. Proven to form Bone. Every Lot. PENTOS OI ALLOGRAFTS MUST DEMONSTRATE ALL FIVE ELEMENTS OF BONE FORMATION BEFORE THEY ARE RELEASED FOR USE. Post sterilization in-vivo testing on each lot must demonstrate the presence of new bone, bone marrow, osteocytes, cartilage and chondrocytes within 28 days in an athymic rat model otherwise we can t call it PentOS OI. In-vitro tests of PentOS OI have demonstrated native levels of BMP-2 up to 19 times the native levels in the control. 100% Allograft Hydratable Inductive Matrix Create your customized osteoinductive graft by combining PentOS OI Max, a 100% allograft Inductive Collagen Matrix (ICM) with your choice of blood, BMA, PRP, I-PRF or simply saline to form a moldable graft which - is cell friendly - Independent laboratory in vitro studies show to be able to maintain between 96% and 116% cell viability after 72 hours. PENTOS OI Max is an osteoinductive matrix - not diluted by any carriers. Available jar sizes: 1cc and 2.5cc PentOS OI Max can resist copious irrigation 100% Allograft DBM Putty PentOS OI Putty is made from 100% human bone without any additional diluent or carriers to diminish its osteoinductive properties. EVERY lot used to manufacture PentOS OI products is verified to be osteoinductive and histologically demonstrate all five elements of bone formation. Proven to form bone. Every time. It s that simple! 100% Allograft Flexible Veneer Graft PentOS OI Flex is a 1 mm thick osteoinductive, demineralized cortical bone graft. When hydrated, this veneer graft becomes pliable and easily adapts to graft sites that would be difficult to treat with particulate or putty grafts. These characteristics make PentOS OI Flex ideally suited for onlay grafting for the repair of shallow bone defects or bone loss. Available sizes: 10x10mm, 15x15mm and 17x10mm 100% Allograft Compressible Bone Matrix PentOS OI Sponge is made of cancellous and demineralized bone, it is available as strips or blocks. Strips: 20x10x10mm and 20x15x7mm Blocks: 10mm³ and 12mm³ Visit our microsite at PentOS-OI.com 6

7 DBM with or without cancellous chips. Demineralized Bone Matrix (DBM) Putty + CMC DBM CMC Demineralized Bone Matrix Putty + CMC + Cancellous bone chips DBM Cancellous CMC CMC CARRIER Natural Plant Derived Carrier Carboxymethylcellulose (CMC) A polysaccharide hydrogel derived from linters of the cotton seed Commonly used in food, cosmetics and pharmaceutical preparations Excellent biocompatibility does not interfere with cell mediated bone formation Odourless, tasteless and nontoxic High viscosity physiologically inert carrier which maintains its interface at the graft site Malleable - can be molded and placed into any shaped defect Excellent dimensional stability does not significantly shrink nor expand Will not migrate from the graft site Resorbs slowly in harmony with new bone formation allowing for cellular and vascular infiltration Haemostatic effect when grafted into a bleeding site FDA classifies CMC as GRAS (generally regarded as safe) Features Quality products Excellent handling Great pricing Ready to use Room temperature storage Open bore syringes E-beam sterilization Double sealed blister packaging Common applications Socket preservation Extraction site repair Implant dehiscence defects Sinus lift procedures Moderate localized ridge defects Available syringe sizes: 0.3 cc 0.5 cc 1 cc 3 cc AVAILABLE IN 0.3 cc SYRINGES 7 Visit our microsite at Citagenix-DBM.com

8 All your bone allografts... under one wing! RAPTOS IRRADIATED BONE PARTICULATES, A NATURAL SCAFFOLD FOR BONE REGENERATION. RAPTOS allograft mineralized bone grafts offer an osteoconductive platform for bone regeneration and Raptos demineralized particles offer an osteoinductive boost. Used either alone or as part of a composite bone graft, allograft bone particulates supply a natural framework facilitating the attachment of osteogenic precursor cells. Premium Blend - This Cortical Mineralized/Demineralized blend combines two of the most popular allograft particles used in dentistry, all in a single syringe! SAFETY INFORMATION Each donor is thoroughly evaluated using medical/ social history questions, medical records, blood tests, culture results, physical examination and autopsy reports (when performed). This process is used to ensure the donor is suitable for donation by allowing to recognize and exclude potential diseases or medical conditions that are unacceptable. Specific lab tests are performed for Syphilis, Hepatitis B and C, HIV and other viruses. All of the donor chart information is evaluated by individuals trained in tissue banking, prior to the processing of the tissue. Tissue grafts are rinsed and soaked in various solutions to minimize transmission of bacteria and viruses. Processing and packaging of the tissue are performed using aseptic technique and occur in a clean room. As an added margin of safety, a low dose gamma irradiation after final packaging of the musculoskeletal grafts is utilized. AATB accredited source and mandatory CTO registered with Health Canada. Raptos prefilled syringes are available in cancellous, cortical, cortico-cancellous,demineralized and Premium Blend particulates ( µm): 0.25 cc, 0.5 cc & 1.0 cc Visit our microsite at Raptos.com 8

9 The science of balanced bone regeneration. SYNTHETIC RESORBABLE BONE SUBSTITUTE GRANULES & PUTTY For patients who express concerns with allografts and xenografts Completely remodels to host bone 25 years of clinical experience ECLIPSE GRANULES & PUTTY 100% SYNTHETIC - COMPLETELY TRANSFORMS TO NATURAL BONE Using the mineral building blocks naturally found in human bone, Eclipse goes a step beyond the realm of everyday hydroxyapatite (HA) and tricalcium phosphate (TCP) with its unique combination of micro and macroporosity technology. 70% overall porosity 2/3 macroporosity 1/3 microporosity Granules: Eclipse Granules, a 100% synthetic (20% HA, 80% TCP), costeffective bone graft matrix used as an alternative to biologic osteoinductive products. Putty: Eclipse Putty is an innovative and moldable bone graft, composed of Hydroxyapatite (HA), Beta Tricalcium Phosphate (ß-TCP) and a hydrogel. Microporosity (pores <10μm) allows the diffusion of biological fluids, by the capillary action, into the three-dimensional matrix. Inside the fine pores of the matrix, biological fluids dissolve ß-TCP producing calcium phosphate ions that are released back into the biological fluids. This saturation of ions leads to precipitation of apatite crystal identical to that of the natural bone minerals. Shortly afterwards, this process creates a surface that promotes bone cell adhesion. MICRO MACRO Granules ( mm) available in syringes of 0.5cc & 1.0cc or in vials of 0.25cc, 0.5cc & 1.0cc Granules ( mm) available in vials of 2.0cc Putty available in syringes of 0.5cc & 1.0cc Macropores (300 to 600 μm) promote a deep invasion of osteogenic cells by osteoconduction. Through the same resorption and formation cycle as the natural bone remodeling process, new bone increases progressively at the expense of Eclipse. 9 Visit our website at CitagenixUSA.com

10 Visit our website at CitagenixUSA.com A wide variety of membrane options BOVINE PORCINE ALLOGRAFT Description Neomem Resorbable collagen membrane derived from highly purified type I collagen fibres from bovine Achilles tendon. Neomem FlexPlus Single layer collagen membrane derived from porcine peritoneum. Neoderm Acellular human dermis available in thicknesses of μm (thin) and μm (thick). Characteristics Cell occlusive Allows nutrient transfer Optimized flexibility and rigidity Either side can be placed towards the soft tissue or bone Easily trimmed and placed, wet or dry Gamma irradiated to sterilize Fixated with sutures or tacks Nonpyrogenic Suture pull out strength between 290g and 350g High suture pull out strength Excellent draping Lower inflammation 3-4 month resorption Easy handling Human derived dermal grafts are decellularized to remove cellular components and preserve the biological properties that promote revascularization and repair. Neoderm acelluar dermis, has the natural elasticity of human skin. Neoderm is minimally processed to remove epidermal and dermal cells while preserving the extracellular matrix of the dermis. The grafts are freeze-dried and sterilized. GTR GBR GTR GBR Replacement of damaged or inadequate tissue for the repair, reinforcement, or supplemental support of soft tissue defects. Applications Resorption 26 to 38 weeks 3 to 4 months 3 to 4 months (thin) 4 to 6 months (thick) Availability 15x20, 20x30 & 30x40 mm 15x20, 20x30 & 30x40 mm 10x10, 10x20, 10x40 & 20x40 mm in either thin ( μm) or thick ( μm) GP (01/2017) GTR Guided Tissue Regeneration GBR Guided Bone Regeneration 10

11 The standard in membrane technology. NEOMEM MEMBRANE IS A TYPE 1 BOVINE COLLAGEN MATRIX INDICATED FOR USE IN GUIDED TISSUE PROCEDURES TO ENHANCE WOUND HEALING. Advantages Higher mechanical strength for membrane stabilization in situ using either sutures or resorbable tacks. Longer in vivo stability and resorption time, weeks, for sustained function. Optimized flexibility and rigidity for better space maintenance which allows for desired tissue in-growth. Either side of the Neomem can be placed towards the soft tissue or bone. Easily trimmed and placed, wet or dry. NEOMEM RESORPTION RATE Available in convenient sizes 15x20 mm 20x30 mm 30x40 mm NeoMem is sterilized by irradiation and packaged in double pouches. EXCEPTIONAL CLINICAL PERFORMANCE Suture pull out strength between 290g and 350g Cell occlusive - retards epithelium down growth Macromolecular pore size allows nutrient transfer WHY MAKE NEOMEM YOUR MEMBRANE OF CHOICE? Highly purified type I collagen fibres derived from bovine Achilles tendon Nonpyrogenic Excellent safety profile Easy in situ placement 11 Visit our microsite at Neomem-membrane.com

12 Strong performance with a supple touch. NEOMEM FLEXPLUS - Native porcine peritoneum Neomem FlexPlus is a single layer collagen membrane derived from porcine peritoneum. Suture pullout testing has shown this membrane to be biomechanically strong yet conformability evaluations demonstrate the ability to adapt to the contour of the surgical site. Neomem FlexPlus hydrates quickly and handling characteristics make surgical placement easy. It can be repositioned easily and placed wet or dry and with either side up. Additionally, in-vitro testing of Neomem FlexPlus shows low tissue inflammation and foreign body giant cell response. INFLAMMATION SCORE Bio-Gide Neomem FlexPlus 4 weeks 8 weeks 12 weeks 16 weeks GIANT CELLS SCORE Bio-Gide Neomem FlexPlus 4 weeks 8 weeks 12 weeks 16 weeks *Published in Science, Technology, Innovation, Feb. 1-5, 2015 All trademarks are the property of their respective owners. Compared to Bio-Gide : Stronger Neomem FlexPlus has 3 times the suture pull out strength compare to Bio-Gide and resorption time of 3-4 months. Neomem FlexPlus can be repositioned once placed. Supple Lack of memory means that Neomem FlexPlus drapes and conforms to the defect site and since both sides are the same, it is easy to place. Better Initial Resorption Rate Compared to Bio-Gide, Neomem FlexPlus initial in-vivo resorption profile suggests that Neomem FlexPlus is more stable. Less Inflammation In-vivo testing also demonstrates that Neomem FlexPlus produced a lower level of early inflammation than Bio-Gide and Neomem FlexPlus shows a lower level of giant cell response. Advantages: High suture pull out strength Excellent draping Lower inflammation 3-4 month resorption Easy handling Available in convenient sizes: 15x20, 20x30 & 30x40 mm Visit our microsite at Neomem-membrane.com 12

13 Natural elasticity of human acellular dermis. NEODERM IS HUMAN ACELLULAR DERMIS, WHICH HAS NATURAL ELASTICITY. These human derived dermal grafts are decellularized to remove cellular components and preserve the biological properties that promote revascularization and repair. Neoderm acellular dermis, has the natural elasticity of human skin. Neoderm is minimally processed to remove epidermal and dermal cells while preserving the extracellular matrix of the dermis. The grafts are freeze-dried and sterilized providing 5 years of shelf life at room temperature. Neoderm can be used to replace damaged or inadequate tissue for the repair, reinforcement, or supplemental support of soft tissue defects. Neoderm is available in a variety of sizes and thickness, and can be shaped with scissors or a scalpel. Neoderm is ideal for the replacement of damaged or inadequate tissue for the repair, reinforcement, or supplemental support of soft tissue defects. Resorption 3 to 4 months (thin) 4 to 6 months (thick) Available in convenient sizes in either thin ( µm) or thick ( µm) 10x10 mm 10x20 mm 10x40 mm 20x40 mm 13 Visit our website at CitagenixUSA.com

14 Collagen Dental Wound Dressings Our Resorbable Wound Dressings are absorbent and porous collagen matrices engineered from purified collagen that is derived from bovine dermis tissue. The thickness and pore structure of these devices allow them to absorb fluid and blood at the defect site. 10 mm x 20 mm Cylindrical shape adapts easily to surgical sites 20 x 40 x 3 mm Thicker sponge shape protects soft tissue 25 x 75 x 1 mm Thinner tape like design for more intricate uses Product Features: Applied directly to the wound and protect the wound and delicate new tissue Aids in wound healing Available in plug, cote and tape form Supplied sterile, non-pyrogenic and for single use only Essentially resorbs within 30 days of placement Indications: Denture sores Oral ulcers (non-infected or viral) Periodontal surgical wounds Suture sites Burns Extraction sites Surgical wounds Traumatic wounds new product Visit our website at CitagenixUSA.com 14

15 Visit our microsites to find out everything you need to know. The complete information on our products. Optimized for perfect viewing on your mobile device or on your computer. Documents, case studies, videos & more at your fingertips.

16 Our management and sales directors are experts in their field with over 20 years of experience in dental devices and grafting materials. Our Customer Service Team is made up of members with extensive experience in regenerative products to help our customers get answers and results. One of the reasons our customers rely on us is because most of our orders are shipped the same day when placed before 3 PM EST info@citagenix.com CitagenixUSA.com GP (04/2017)