BONE void FILLER. Beta-tricalcium phosphate ( b-tcp) bone graft substitute. OvERvIEW BROCHURE

Transcription

1 chronos BONE void FILLER Beta-tricalcium phosphate ( b-tcp) bone graft substitute OvERvIEW BROCHURE

2 chronos STRIP chronos Strip is a synthetic bone void filler manufactured from chronos Beta-Tricalcium Phosphate (b-tcp) Granules and a resorbable polymer [poly(lactide co-ε-caprolactone)]. The result is a porous, osteoconductive, three-dimensional composite that is flexible, with excellent memory characteristics. chronos Strip conforms to the implant site, allowing site-specific placement. Each strip is sterile-packaged in a perfusion pack, allowing easy perfusion with autologous bone marrow and/or blood. Perfusion with bone marrow aspirate (BMA) provides a favorable environment for bony ingrowth. chronos Strip Mx takes chronos Strip one step further by adding cuts in the strip to facilitate implantation. The easy removal of chronos Strip Mx s notched corners assists in implantation beneath the rod, and stabilizes the graft material along the posterolateral gutters. chronos Strip features A composite pairing of the structure of an osteoconductive b-tcp ceramic scaffold with the handling advantage of a resorbable polymer Replaced with new bone in 6 to 18 months during the bone remodeling process 1,2* Can be used alone or with autograft 100% synthetic, reducing the chance for disease transmission from human tissue Standardized pores are within the size range identified as ideal for bony ingrowth 3 chronos Strip Mx features chronos Strip Mx s T-shaped design wedges the implant below the rod chronos Strip Mx s Level Packs consist of two strips inside each perfusion pouch and take the guesswork out of how much graft to use per level After removal, the marrow-rich corner of chronos Strip Mx can be mixed with autograft and placed in the posterolateral gutters in contact with the strips. chronos Strip may be folded, twisted, cut, or sutured intraoperatively for optimal placement. The notched corner design in chronos Strip Mx allows manual removal by tearing or cutting prior to implantation. Perforations in chronos Strip Mx s design help it conform to patient anatomy, providing an osteoconductive scaffold beneath the rod and between the pedicular screws. chronos Strip Mx is packaged with 2 strips to a perfusion pouch, which allows thorough wetting and bilateral implantation along one level of the posterolateral spine. *It is unknown how the results of these studies will correlate with clinical performance. DePuy Synthes Companies chronos Bone Void Filler

3 INDICATIONS AND CONTRAINDICATONS Indications chronos Strip is indicated for: Bony voids or gaps that are not intrinsic to the stability of the bony structure Use in the treatment of bony defects created surgically or through traumatic injury chronos Strip, combined with autogenous blood and/or bone marrow or autograft, is intended to be used in the spine for posterolateral fusion. Following placement into the bony void, chronos Strip resorbs and is replaced with bone during the healing process. Contraindications* chronos Strip should not be used in: The presence of infection, eg, inflammatory, bacterial bone diseases (post-traumatic or chronic osteomyelitis) and soft tissue infections Untreated malignant myeloma, Burkitt s lymphoma, and other lymphomas Defects in the region of unclosed epiphyseal cartilage (ie, fractures of the growth plate) Segmental defects of long bones Areas which are subjected to excessive impact or stress Areas where there is significant vascular impairment proximal to the graft site The presence of metabolic or systemic bone disorders that affect bone or wound healing *For complete contraindications, adverse events, and cautions, please refer to the package insert. chronos Bone Void Filler DePuy Synthes Companies 1

4 chronos Strip Osteoconductive chronos Strip perfused with bone marrow was compared to autograft in a study of 66 skeletally mature New Zealand white rabbits. When evaluated by manual palpation, Faxitron x-ray, and micro-ct, chronos Strip showed nonstatistically significant advantages to autograft in terms of fusion.* chronos Strip Autograft To facilitate the homogenous saturation of chronos Strip with a patient s own bone marrow and/or blood prior to implantation, chronos Strip is provided in a perfusion pack with a Luer fitting to allow attachment of a syringe, such as the one found in the PROCURE Bone Marrow Aspiration System. Perfuse the chronos Strip by gently pumping the syringe plunger 3 to 5 times or until the implant appears wetted throughout. Recommended volumes for perfusion of chronos Strip Strip Size (mm) Perfusion volume Range (cc) 47 x 18 x (2 strips) 50 x 25 x x 25 x x 25 x x 25 x Representative micro-ct and histological images of the fusion masses from the chronos Strip-treated group and the autografttreated group. Newly grown bone is displayed in dark purple. Fusion assessment method chronos Strip Autograft + BMA Manual Palpation 86.7% 68.8% Faxitron 100% 87.5% Micro-CT 100% 66.6% Zhang K, Cunningham M, van der Meulen M, Huang P, Harten R, Cammisa F. Improved spine fusion outcomes with a novel ceramic-polymer composite. Presented at the 54th Annual Meeting of the Orthopaedic Research Society, San Francisco, CA, *Note: Results in rabbits may not necessarily be indicative of results in humans. 1 DePuy Synthes Companies chronos Bone Void Filler

5 chronos GRANULES AND PREFORMS Overview chronos Granules and Preforms are synthetic, osteoconductive, resorbable calcium phosphate bone substitutes that can supplement autogenous bone. chronos Bone Graft Subsitute potentially eliminates the need for autologous bone harvesting, thus potentially reducing overall patient morbidity. chronos Granules and Preforms are manufactured in a cleanroom environment from a biocompatible, radiopaque material, Beta-Tricalcium Phosphate (b-tcp). This material contains two of the main mineral constituents of bone, calcium, and phosphate. chronos Bone Graft Substitute has been used clinically in Europe for more than 20 years, under the name CEROS 82. With its synthetic manufacturing process, chronos Beta-Tricalcium Phosphate shows reliable and standardized biomechanical properties. chronos Bone Void Filler DePuy Synthes Companies 3

6 chronos Granules and Preforms Indications chronos Bone Graft Substitute is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. chronos Bone Graft Substitute is indicated for use in the treatment of bony defects created surgically or through traumatic injury. chronos Bone Graft Substitute is intended to be gently packed or placed into bony voids or gaps of the skeletal system (ie, the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronos Bone Graft Substitute resorbs and is replaced with bone during the healing process. Contraindications* chronos Bone Graft Substitute should not be used in: The presence of infection, eg, inflammatory, bacterial bone diseases (post-traumatic or chronic osteomyelitis) and soft tissue infections Untreated malignant myeloma, Burkitt s lymphoma, and other lymphomas Defects in the region of unclosed epiphyseal cartilage (ie, fractures of the growth plate) Segmental defects of long bones Areas which are subjected to excessive impact or stress Areas where there is significant vascular impairment proximal to the graft site The presence of metabolic or systemic bone disorders that affect bone or wound healing *For complete contraindications, adverse events and cautions, please refer to the package insert. 4 DePuy Synthes Companies chronos Bone Void Filler

7 chronos Granules and Preforms Biocompatible Biocompatibility is defined as a material s property to be compatible with a biological system. The biocompatibility depends primarily on the material s chemical composition, its three-dimensional structure, and its surface topography. Bone is a composite material consisting mainly of calcium and phosphate, the two main components of chronos Beta-Tricalcium Phosphate. Calcium phosphate minerals have been widely used as bone substitute materials. chronos Bone Graft Substitute is made from pure b-tcp and its long-term biocompatibility and the absence of any cytotoxic effects has been demonstrated in animal studies.* Histologic verification: Simultaneous resorption and new bone formation osteoid (blue) osteoblasts (dark blue) bone (purple) chronos Beta-Tricalcium Phosphate (gray) chronos Beta-Tricalcium Phosphate meets the requirements of ASTM standard F1088, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. In addition, chronos Beta-Tricalcium Phosphate has passed tests for biocompatibility. chronos Beta-Tricalcium Phosphate at 12 weeks, in a rabbit critical-sized defect model, in the advanced stages of resorption. The remaining material is interwoven with osteoid and mineralized bone. Osteoblasts and osteoid seams are visible.** *Data on file at DePuy Synthes Companies. **Note: Results in rabbits may not necessarily be indicative of results in humans. chronos Bone Void Filler DePuy Synthes Companies 5

8 chronos Granules and Preforms Engineered for Osteoconductivity Provides scaffolding To facilitate the bone healing process, bone void fillers should at least be osteoconductive. This is mainly influenced by three factors: overall porosity, interconnection of macropores and presence of micropores. chronos Beta-Tricalcium Phosphate has been designed to optimize these features so that it can closely mimic cancellous bone and provide a scaffold for bony infiltration. Overall porosity chronos Beta-Tricalcium Phosphate has a total porosity of 60% for the granules and 70% for the preforms. A high porosity enhances the osteoconductivity, although a porosity that is too high weakens the material s compressive strength. chronos Beta-Tricalcium Phosphate benefits from the highest possible degree of porosity without compromising the mechanical strength. Distribution 35% 30% 25% 20% 15% 10% 5% 0% <100 < Pore Size (µm) Figure 1: Distribution of chronos Beta-Tricalcium Phosphate macropores >500 Macropores The macropores of chronos Beta-Tricalcium Phosphate are mainly distributed within a range of 100 µm 500 µm (Figure 1). This offers the optimal environment for vascularization and bony infiltration. 3 In addition, the macropores are interconnected to allow bone formation throughout the entire implant (Figure 2). Micropores chronos Beta-Tricalcium Phosphate contains micropores, which are spaces within the material smaller than 10 µm. The microporosity increases the surface area where new bone forms and allows circulation of body fluids (Figure 3). Figure 2: chronos Beta-Tricalcium Phosphate macrostructure Figure 3: chronos Beta-Tricalcium Phosphate microstructure 4 6 DePuy Synthes Companies chronos Bone Void Filler

9 Feature Benefit Advantage Osteoconductive Provides a scaffold for bony ingrowth Gives bone cells a path upon which to lay down new host bone Fully synthetic No risk of disease transmission from Ease of mind for patients human tissue Standardized pore sizes macropores: 100 µm 500 µm Optimal environment for Promotes bone formation throughout vascularization and bony infiltration the entire implant, not just at the periphery micropores: <10 µm Increases surface area where new bone forms and allows circulation of fluids throughout the implant Replaced with new bone in 6 18 months Resorption rate is similar to the Replaced with bone in a timely manner during bone remodeling process 1,2 * regeneration of new bone Radiopaque Enables visualization of implant Easy to see on radiograph to verify position correct placement Can be mixed with blood and bone Osteogenic cells are naturally found Increases biological activity at marrow aspirate (BMA) in blood and BMA defect site Ready to use off the shelf Potentially avoids morbidity and risk Confidence about quality and of complications from second surgical quantity of harvested autograft site to harvest bone graft Sufficient quantity of bone OR cost reduction graft substitute 60 70% porous Provides structure for bony Three-dimensional integrity is not ingrowth without loss of stability compromised *It is unknown how the results of these studies will correlate with clinical performance. chronos Bone Void Filler DePuy Synthes Companies 7

10 PROCURE BONE MARROW ASPIRATION KIT Features Five side holes draw marrow from a larger area A 3-sided stylet tip reduces the force required to penetrate dense cortical bone The sharp serrated tip and oversized handle allow improved control during needle insertion Etched lines on the distal tip of the needle assist in placement; marked in 1 cm increments with a thick line at 5 cm and a double line at 10 cm Indications The PROCURE Bone Marrow Aspiration System is intended for aspirating bone marrow. Includes 20 ml syringe with Luer lock fitting and 11 gauge J style bone marrow aspiration needle. Available in 11 cm and 15 cm lengths. Sterile packaged. 11 gauge needle with side holes S 11 cm S 15 cm 11 gauge needle without side holes S 15 cm 8 DePuy Synthes Companies chronos Bone Void Filler

11 PRODUCT INFORMATION chronos Strip Beta-tricalcium phosphate bone void filler with resorbable polymer, sterile Dimensions S 50 mm x 25 mm x 3 mm S 100 mm x 25 mm x 3 mm S 50 mm x 25 mm x 6 mm S 100 mm x 25 mm x 6 mm chronos Strip MX S 47 mm x 18 mm x 3 mm (2/pkg.) chronos Granules Beta-tricalcium phosphate bone void filler, sterile Small Granule Size Volume S 0.7 mm 1.4 mm 1 cc Medium Granule Size Volume S 1.4 mm 2.8 mm 5 cc S 1.4 mm 2.8 mm 10 cc S 1.4 mm 2.8 mm 20 cc Large Granule Size Volume S 2.8 mm 5.6 mm 5 cc S 2.8 mm 5.6 mm 10 cc S 2.8 mm 5.6 mm 20 cc Shown actual size chronos Bone Void Filler DePuy Synthes Companies 9

12 Product Information chronos Preforms Small Cylinders Beta-tricalcium phosphate bone void filler, sterile Small Cylinders -CP S Size S Size S Size S Size S Size S Size S Size S Size 12 Small Cylinders -L S Size S Size S Size S Size S Size S Size S Size S Size 12 Diameter 5 mm 12 mm chronos Preforms Synthetic VerteFill Cylinders Beta-tricalcium phosphate bone void filler, sterile Diameter S S 15 mm 17 mm 20 mm Diameter 10 DePuy Synthes Companies chronos Bone Void Filler

13 PROCURE Bone Marrow Aspiration Kits, sterile Item Number S S S Description 11 gauge, 11 cm multi-port needle (side holes) 11 gauge, 15 cm multi-port needle (side holes) 11 gauge, 15 cm single-port needle (without side holes) 5 cm 10 cm chronos Bone Void Filler DePuy Synthes Companies 11

14 References 1. Eggli PS, Müller W, Schenk RK. Porous hydroxyapatite and tricalcium phosphate cylinders with two different pore size ranges implanted in the cancellous bone of rabbits a comparative histomorphometric and histologic study of bony ingrowth and implant substitution. Clin Orthop Relat Red. 1988;232: Buser D, Hoffmann B, Bernard JP, Lussi A, Mettler D, Schenk RK. Evaluation of filling materials in membrane protected bone defects a comparative histomorphometric study in the mandible of miniature pigs. Clin Oral Implants Res. 1998;9: Gazdag AR, Lane JM, Glaser D and Forster RA. Alternatives to autogenous bone graft: efficacy and indications. J Am Acad Orthop Surg. 1998;3(1): Microstructure of chronos (Source: Dr. M Bohner, RMS Foundation; Dr. G Richards, AO Research). 11 DePuy Synthes Companies chronos Bone Void Filler

15 Limited Warranty and Disclaimer: DePuy Synthes Products, LLC 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. To order in the U.S. call, Johnson & Johnson Health Care Systems Inc. Customer Support Services at Not all products are currently available in all markets. Some devices listed in this brochure may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Manufactured by (United States): Synthes USA Products, LLC 1101 Synthes Avenue Monument, CO Telephone: (610) To order: (800) Fax: (610) Legal manufacturer (Canada): Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) DePuy Synthes All rights reserved. DSUS/MOC/0914/0100 1/15