RAPIDSORB RAPID RESORBABLE FIXATION SYSTEM. A new resorbable approach to Alveolar bone augmentation

Transcription

1 RAPIDSORB RAPID RESORBABLE FIXATION SYSTEM A new resorbable approach to Alveolar bone augmentation

2 RAPIDSORB RAPID RESORBABLE FIXATION SYSTEM Bone Graft Containment The RapidSorb Rapid Resorbable Fixation System can be used for bone graft containment in the maxilla or mandible and can be cut and contoured in a hot water bath to fit the bony anatomy. Features Rapid resorbable implants maintain appropriate fixation for bone healing for approximately eight (8) weeks postoperatively. Resorbs in 12 months Degrades without late inflammatory complications and foreign-body responses that have been observed with semicrystalline structures such as poly (L-lactide) 1,2 Eliminates secondary surgeries for implant removal Proven biocompatible material 3 Radiolucent polymer does not interfere with intraor postoperative radiographs 4,5 Polymer strength is not affected by radiation therapy 6,7 Case Study Intraoperative photo of horizontal and vertical augmentation of mandibular central incisors, using RapidSorb mesh and screws. 1.5 mm RapidSorb contourable mesh, 0.5 mm thick is fixated with two resorbable screws apical to teeth #23 and #26.* 1. J.E. Bergsma, et al. Late Degradation Tissue Response to Poly (L-lactide) Bone Plates and Screws. Biomaterials. 1995, 16: O.M. Böstman, H.K. Pihlajamaki. Late Foreign-Body Reaction to an Intraosseous Bioabsorbable Polylactic Acid Screw. The Journal of Bone and Joint Surgery. 1998, 80A (12): Based on biocompatibility testing per ISO :1997(E) conducted by Synthes (USA). 4. D.A. Rikli, P. Regazzoni, S.M. Perren. Is There a Need for Resorbable Implants or Bone Substitutes? International Journal of the Care of the Injured S-B D. Rovinsky, R.C. Durkin, N.Y. Otsuka. The Use of Bioabsorbables in the Treatment of Children s Fractures. Techniques in Orthopedics. 1998; 13: M. Mohiuddin, et al. High-Dose Spatially-Fractionated Radiation (GRID): A New Paradigm in the Management of Advanced Cancers. International Journal of Radiation Oncology Biology Physics. 45 (3): F.R. Rozema, P.C. Levedag, R.R.M. Bos, et al. Influence of Resorbable Poly (L-lactide) Bone Plates and Screws on the Dose Distribution of Radiotherapy Beams. International Journal of Oral Maxillofacial Surgery. 1990; 116: * Results from case studies are not predictive of results in other case studies. Results in other cases may vary. DePuy Synthes RapidSorb Rapid Resorbable Fixation System

3 INDICATIONS AND CONTRAINDICATIONS Indications The DePuy Synthes Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws, and tacks may be used in non-load-bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. Contraindications* These devices are not intended for use in load-bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The DePuy Synthes Rapid Resorbable System is not intended for areas with active or latent infection, or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. * Please see Directions for Use for complete contraindications, warnings, and precautions. RapidSorb Rapid Resorbable Fixation System DePuy Synthes

4 BASIC SCIENCE The implants of the RapidSorb Rapid Resorbable Fixation System are manufactured from 85:15 poly (L-lactide-coglycolide). This copolymer is formed by combining L-lactide and glycolide, which maximizes the advantageous characteristics of each component and provides a material well suited for craniofacial reconstruction (Figure 1). 1 85:15 poly (L-lactide-co-glycolide) is a linear, substantially amorphous, random copolymer, and retains approximately 85% of its initial bending strength after 8 weeks (Figure 2). A significant benefit of this composition is the amorphous microstructure, which is readily resorbed by the body (Figure 3). First, water penetrates the bulk of the device and breaks the chemical bonds along the backbone of the polymer chains in a process called hydrolysis. As the bonds are broken, producing shorter polymer chains, the molecular weight of the polymer decreases, and the strength of the material decreases. Eventually, the material loses its integrity and breaks down into smaller and smaller particles. These smaller pieces are then phagocytized (ingested and digested by the cells of the body). The polymer is broken down into lactic and glycolic acids, which are subsequently eliminated through natural body metabolism in the form of water and CO 2, without toxic tissue accumulation. 8 L-Lactide (85%) L-lactide polymers are semi-crystalline, characterized by high strength and a long degradation time. Strength Retention (%) Glycolide (15%) Glycolide polymers are amorphous, characterized by lower strength and more rapid degradation Time (weeks) 3 Bulk Hydrolysis H 2 O H 2 O (polymer) (short polymer chains) Lactic and Glycolic Acids 8. R.A. Miller, J.M. Brady, D.E. Cutright. Degradation Rates of Oral Resorbable Implants (polylactates and polyplyconates): Rate Modification with Changes in PLA/PGA Copolymer Ratios. The Journal of Biomedical Materials. 1977; 11: Metabolism Cell CO 2 H 2 O DePuy Synthes RapidSorb Rapid Resorbable Fixation System

5 RAPIDSORB IMPLANTS Screws Available in 1.5 mm and 2.0 mm diameters Cruciform recess allows easy pickup, insertion, and removal Emergency screws can be placed easily by tapping through the original screw 2.0 mm screws can be used with 1.5 mm plates as primary or emergency screws Tacks Available in 1.5 mm diameter Simple drill-and-push insertion eliminates the need for tapping and threading Shear strength comparable to Synthes 1.5 mm rapid resorbable cortex screws Centering socket helps maintain alignment between tack and driver during insertion Mesh Contourable mesh permits optimal anatomic conformity without cutting or kinking. Cutting the mesh along the long slots gives the user a smooth edge with which to work (recommended minimum plate size after cutting is 2 round holes x 3 round holes, see picture at right). RapidSorb Rapid Resorbable Fixation System DePuy Synthes

6 RapidSorb Implants Taps Available with self-drilling tips 3, 4, 5, 6, 8 mm stop lengths available Self-drilling tap Fixed stop length, self-drilling tap Water bath system Warms a bath of sterile water or saline solution to 70 C to quickly heat resorbable plates to a malleable state Removable water tray and sterility cover can be cleaned and sterilized Reusable sterility cover or disposable sterile drape allows use in the sterile field Plates can be heated up to 10 times DePuy Synthes RapidSorb Rapid Resorbable Fixation System

7 PRODUCT INFORMATION Implants s s s s s s s s s s s s s s s s 1.5 mm Rapid Resorbable Cortex Screws, sterile (2/pkg) 3 mm 4 mm 5 mm 6 mm 8 mm 2.0 mm Rapid Resorbable Cortex Screws, sterile (2/pkg) 4 mm 6 mm 8 mm 1.5 mm Rapid Resorbable Contourable Mesh Plates, sterile 50 mm x 50 mm x 0.25 mm thick 30 mm x 40 mm x 0.25 mm thick 20 mm x 30 mm x 0.25 mm thick 15 mm x 25 mm x 0.25 mm thick 50 mm x 50 mm x 0.5 mm thick 30 mm x 40 mm x 0.5 mm thick 20 mm x 30 mm x 0.5 mm thick 15 mm x 25 mm x 0.5 mm thick Instruments Screwdriver Handle, with mini-quick coupling, small mm Cruciform Screwdriver Blade, with Spring Holding Sleeve, mini-quick coupling mm Cruciform Screwdriver Blade, with Spring Holding Sleeve, mini-quick coupling Bending Template for 1.5 mm/2.0 mm Resorbable Mesh Plates 75 x Plate Holding Forceps Scissors for Resorbable Mesh Plates Drill Bits with Stop, mini quick coupling, 44.5 mm long mm Drill Bit, with 4 mm Stop mm Drill Bit, with 6 mm Stop mm Drill Bit, with 8 mm Stop mm Drill Bit, with 4 mm Stop mm Drill Bit, with 6 mm Stop mm Drill Bit, with 8 mm Stop s s s s s s s s Self Drilling Taps with Stop for 1.5 mm Resorbable Cortex Screws, mini-quick coupling, sterile 3 mm stop 4 mm stop 5 mm stop 6 mm stop 8 mm stop Self Drilling Taps with Stop for 2.0 mm Resorbable Cortex Screws with 1.5 mm Plates, mini-quick coupling, sterile 4 mm stop 6 mm stop 8 mm stop Instrument Trays Small Instrument Tray Lid, for Resorbable Fixation System Small Instrument Tray Base, for Resorbable Fixation System Instrument Insert, for Resorbable Instrument Trays Finger Mat Insert, for Resorbable Instrument Trays Accessories Water Bath System includes: Water Bath Heater Water Bath Tray Water Bath Sterility Cover RapidSorb Rapid Resorbable Fixation System DePuy Synthes

8 Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Not all products are currently available in all markets. DePuy Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) DePuy Synthes CMF, a division of DOI All rights reserved. RapidSorb and Synthes are trademarks of Synthes, Inc. or its affiliates. J10346-C 5/13 DS Studio