ORTHOVISC Brochure
Orthovisc Brochure ORTHOVISC_brochure ORTHOVISC_brochure 2 2013 pdf 258413772373414384
2013-03-17
: Pdf Orthovisc Brochure ORTHOVISC_brochure 3 2013 pdf
Open the PDF directly: View PDF .
Page Count: 8
Download | ![]() |
Open PDF In Browser | View PDF |
natural balance between science and nature. A ORTHOVISC : Close to ® High Molecular Weight Hyaluronan Orthovisc®: Closely matches healthy synovial fluid. 0.6 1.9 1.4 1-2.9 OA of the knee1,2 60 46 3-4 ORTHOVISC®1,3 117 45 Healthy 4,5 Properties of synovial fluid: Molecular weight (million daltons) Elasticity (Pa at 2.5 Hz) Viscosity (Pa at 2.5 Hz) Orthovisc® has the highest concentration of hyaluronic acid (HA) amongst available viscosupplements. Hyaluronic acid concentration – mg/mL HYALGAN® SUPARTZ® SYNVISC® SYNVISC-ONE® 7 8 5 ORTHOVISC® EUFLEXXA TM9 6 10 8 3 15 High concentration of HA in synovial fluid (SF) is essential for normal joint function:10 • Responsible for shock absorbing and lubricating properties of SF, which are diminished by osteoarthritis • Reduces wear and attrition of cartilage • Important for nutrition of cartilage • Eliminates metabolites and unhealthy substances from joint cavity nature. High purity may minimize risk of inflammatory reactions.11,12 • ORTHOVISC® contains no additives • Derived from bacterial cells, it can be prescribed to patients with known avian allergies • Repeat courses may be safely administered3 Comparison of syringe contents ORTHOVISC® 2 mL SYNVISC® 2 mL SYNVISC-ONE® 6 mL* HYALGAN 2 mL ® SUPARTZ 2.5 mL ® EUFLEXXA 2 mL TM Hyaluronan 30 mg Hylan polymers (hylan A + hylan B) 16 mg Sodium hyaluronate 20 mg Sodium hyaluronate 25 mg Sodium hyaluronate 20 mg Sodium chloride 18 mg Sodium chloride 17 mg Sodium chloride 17 mg Sodium chloride 21.25 mg Sodium chloride 17 mg *SYNVISC-ONE® 6 mL = 3 times content of SYNVISC® 2 mL. Visual Depiction of content not to scale. Illustrations for presentation purposes only. No additives 0.32 mg Disodium hydrogen phosphate 0.08 mg Sodium dihydrogen phosphate monohydrate 0.1 mg Monobasic sodium phosphate 1.2 mg Dibasic sodium phosphate 1.34 mg dibasic sodium phosphate dodecayhdrate 0.04 mg Sodium dihydrogen phosphate dihydrate 1.12 mg Disodium hydrogen phosphate dodecahydrate 0.1 mg Sodium dihydrogen phosphate dihydrate ORTHOVISC : Efficacy that ® Proven efficacy across 26 weeks of randomized controlled trials.3,13 • ORTHOVISC® provided significant improvement in WOMAC pain score versus saline at all time points • Up to 6 months of symptom relief with 3 or 4 injections Significant improvement in WOMAC pain score (effectiveness population†)13 WOMAC Pain Score Mean Change from Baseline 0 ORTHOVISC® (n = 66) Saline (n = 69) -1 -2 -3 -4 -5 -6 * 0 5 * 10 * * 15 20 Visit Week *Statistically significant difference between treatment groups (p<0.05 vs. control group). † Patients with contralateral WOMAC knee pain score less than 12. • 58% of patients achieved 5 units or greater improvement in mean pain score (control = 40%)13 • Twice as many achieved 7 units or greater improvement (ORTHOVISC® 30% vs. control 17%)13 25 30 matches expectation. Don’t wait until it’s too late for a non-surgical option. Pain Scale 0 1 2 Mild Pain 3 4 5 6 Moderate Pain 7 8 9 10 Severe Pain • Diagnose and treat early for improved results1 • ORTHOVISC® demonstrated statistically and clinically significant symptom improvement when used in patients with mild to moderate knee osteoarthritis13‡ • The American College of Rheumatology places viscosupplementation early in treatment paradigm14 ‡ ellgren-Lawrence Grade II or III radiographic evidence of knee K osteoarthritis, WOMAC Osteoarthritis Index pain score of 13 or greater (possible range, 5-25). ORTHOVISC® High Molecular Weight Hyaluronan ORTHOVISC® High Molecular Weight Hyaluronan CAUTION Federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Additional adverse event information was obtained from an open label study (OAK0101). The objective of the open label study was to evaluate the safety of a repeat course of intra-articular ORTHOVISC®. The patients enrolled in the open label study were previously enrolled in one of the randomized studies (OAK2001). Patients who completed OAK2001 and had persistent pain in the index knee received 3 weekly injections of ORTHOVISC® six months following the first treatment course and were followed for 6 weeks. Of 190 eligible patients, 127 had been assigned to either 4 injections of ORTHOVISC® or to 3 injections of ORTHOVISC® plus one arthrocentesis in OAK2001 and therefore underwent two courses of ORTHOVISC® treatment between the two studies. In OAK0101, adverse event profiles (type, frequency and severity of adverse events) were comparable among the three treatment groups (those who had undergone a previous series of 3 or 4 ORTHOVISC® injections and those who received only arthrocentesis in OAK2001) and were similar to those seen in the OAK2001 study and the integrated safety analysis. Table 2 compares adverse event data for patients receiving ORTHOVISC® among the integrated safety analysis (“Single Treatment”), the OAK2001 randomized study (“Single Treatment”) and the OAK0101 retreatment study (“Repeat Treatment”). DESCRIPTION ORTHOVISC® is a sterile, non-pyrogenic, clear, viscoelastic solution of hyaluronan contained in a single-use syringe. ORTHOVISC® consists of high molecular weight (1.0-2.9 million daltons), ultra-pure natural hyaluronan dissolved in physiological saline. Hyaluronan is a natural complex sugar of the glycosaminoglycan family. ORTHOVISC® is derived from bacterial cells. INDICATIONS ORTHOVISC® is indicated in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. CONTRAINDICATIONS • Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations. • Do not administer to patients with known hypersensitivity (allergy) to gram positive bacterial proteins. • Do not inject ORTHOVISC® in the knees of patients with infections or skin diseases in the area of the injection site or joint. WARNINGS • Do not concomitantly use disinfectants containing quarternary ammonium salts for skin preparation as hyaluronic acid can precipitate in their presence. • Transient increases in inflammation in the injected knee following ORTHOVISC® injection have been reported in some patients with inflammatory osteoarthritis. PRECAUTIONS General • Strict aseptic injection technique should be used during the application of ORTHOVISC®. • The safety and effectiveness of the use of ORTHOVISC® in joints other than the knee have not been demonstrated. • The effectiveness of a single treatment cycle of less than 3 injections has not been established. Pain relief may not be seen until after the third injection. • The effectiveness of ORTHOVISC® has not been established for more than one course of treatment. • STERILE CONTENTS. The pre-filled syringe is intended for single use only. The contents of the syringe should be used immediately after opening. Discard any unused ORTHOVISC®. Do not resterilize. • Do not use ORTHOVISC® if the package has been opened or damaged. • Store ORTHOVISC® in its original package at room temperature (below 77°F/25°C). DO NOT FREEZE. • Remove joint effusion, if present, before injecting ORTHOVISC®. • Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject ORTHOVISC® for the indicated use. Information for Patients • Transient pain or swelling may occur after the intra-articular (IA) injection. • As with any invasive joint procedure, it is recommended that patients avoid strenuous activity or prolonged (i.e., more than one hour) weight-bearing activities such as running or tennis within 48 hours following the intra-articular injection. Use in Specific Populations • Pregnancy: The safety and effectiveness of the use of ORTHOVISC® in pregnant women has not been tested. • Nursing Mothers: It is not known if ORTHOVISC® is excreted in human milk. The safety and effectiveness of the use of the product in lactating women has not been tested. • Children: The safety and effectiveness of the use of ORTHOVISC® in children has not been tested. Table 2 Comparison of local individual adverse events reported on a by-patient basis between single and repeat treatment. Adverse Event Any Adverse Event Injection site erythema Injection site edema Injection site pain Injection site reaction NOS1 Pain NOS1 Arthralgia Arthritis NOS1 Arthropathy NOS1 Baker’s cyst Bursitis Joint disorder NOS1 Joint effusion Joint stiffness Joint swelling Localized osteoarthritis Aggravated osteoarthritis Knee arthroplasty ORTHOVISC Single Treatment N = 562 349 (62.1%) 2 (0.4%) 5 (0.9%) 14 (2.5%) 1 (0.2%) 14 (2.5%) 71 (12.6%) 4 (0.7%) 5 (0.9%) 2 (0.4%) 6 (1.1%) 2 (0.4%) 2 (0.4%) 3 (0.5%) 4 (0.7%) 5 (0.9%) 2 (0.4%) 3 (0.5%) ORTHOVISC Single Treatment N = 247 136 (55.1%) 2 (0.8%) 1 (0.4%) 3 (1.2%) 0 (0%) 3 (1.2%) 20 (8.1%) 1 (0.4%) 0 (0%) 0 (0%) 2 (0.8%) 0 (0%) 2 (0.8%) 0 (0%) 2 (0.8%) 3 (1.2%) 2 (0.8%) 0 (0%) ORTHOVISC Repeat Treatment N = 127 39 (30.7%) 0 (0%) 0 (0%) 3 (2.4%) 4 (3.1%) 0 (0%) 8 (6.3%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (0.8%) 0 (0%) 2 (1.6%) 1 (0.8%) 0 (0%) 0 (0%) CLINICAL STUDIES The effectiveness of ORTHOVISC® for the treatment of osteoarthritis of the knee was evaluated in three main studies; two randomized, controlled, double-blind multicenter studies (OAK9501 and OAK2001) that involved unilateral treatment, and one study (OAK9801) that involved bilateral treatment. Because bilateral treatment confounded the assessment of effectiveness of the OAK9801 study, the effectiveness data are summarized for the OAK9501 and OAK2001 studies. Safety data for all three studies are reported in “Adverse Events.” Adverse events occurring at >5% of the overall integrated population included: arthralgia (12.6% in the ORTHOVISC® group, 17.2% in the saline group, and 0.8% in the arthrocentesis group); back pain (6.9% in the ORTHOVISC® group, 12.2% in the saline group, and 4.9% in the arthrocentesis group); and headache NOS (12.1% in the ORTHOVISC® group, 16.6% in the saline group, and 17.9% in the arthrocentesis group). Injection site adverse events (including erythema, edema, pain and reaction NOS) occurred at rates of 0.4%, 0.9%, 2.5% and 0.2%, respectively, in the ORTHOVISC® group, compared to 0.0%, 0.3%, 2.0%, and 0.7% in the saline group and 0.0%, 0.0%, 0.8% and 0.8% in the arthrocentesis group. Local adverse events reported on a bypatient basis for the combined ITT populations of the three studies are presented in Table 1. Study Design/Analysis The objective of the randomized studies was to assess the effectiveness of ORTHOVISC® for the treatment of joint pain of patients with idiopathic osteoarthritis of the knee. The OAK9501 study randomized patients to 3 weekly injections of either ORTHOVISC® (O3) or saline. The OAK2001 study randomized patients to one of three treatments: 4 ORTHOVISC® injections (O4), 3 ORTHOVISC® injections + 1 arthrocentesis (O3A1) procedure, or 4 arthrocentesis (A4) procedures. Follow-up occurred at weeks 7/8, 11/12, 15/16 and 21/22, with final followup at week 27/28. When each study was analyzed individually, the primary analyses for each study did not show statistical significance. A combined analysis was additionally performed. The combined data consisted of data obtained from a subgroup of patients from each of the studies (the “ITT Subgroup” from OAK9501 and the “Evaluable Subgroup” from OAK2001) who had Kellgren-Lawrence radiographic grades of II or III at baseline and WOMAC pain in the contralateral knee of <175 mm (out of 500) and is referred to as the effectiveness subgroup population. For the effectiveness subgroup population, the primary effectiveness analysis performed was to determine the proportion of patients achieving a 20% improvement from baseline in the WOMAC Pain Score in conjunction with a minimum absolute improvement of 50 mm from baseline in the WOMAC Pain Score, and a 40% and 50% improvement from baseline in WOMAC Pain Score at four assessment points between Weeks 7/8 to 21/22 for the index knee. Table 1 Local individual adverse events reported on a by-patient basis for the combined ITT populations of the three studies. Study Population OAK9501 included 226 patients at 10 centers, and OAK2001 involved 373 patients at 24 centers. Within the individual studies, baseline and demographic variables were similar among groups. Table 3 below summarizes the baseline and patient demographic characteristics for the combined effectiveness subgroup. ADVERSE EVENTS ORTHOVISC® was investigated in 3 randomized, controlled clinical studies conducted in the U.S. An integrated safety analysis was conducted, pooling the ORTHOVISC® groups from the 3 studies and pooling the control groups, which were either intra-articular saline injections or arthrocentesis. In the integrated analysis, there were 562 patients in the groups treated with ORTHOVISC® (434 receiving 3 injections and 128 receiving 4 injections), 296 in the group treated with physiological saline, and 123 in the group treated with arthrocentesis. Adverse Event Any Adverse Event Injection site erythema Injection site edema Injection site pain Injection site reaction NOS1 Pain NOS1 Arthralgia Arthritis NOS1 Arthropathy NOS1 Baker’s cyst Bursitis Joint disorder NOS1 Joint effusion Joint stiffness Joint swelling Localized osteoarthritis Aggravated osteoarthritis Knee arthroplasty ORTHOVISC N = 562 349 (62.1%) 2 (0.4%) 5 (0.9%) 14 (2.5%) 1 (0.2%) 14 (2.5%) 71 (12.6%) 4 (0.7%) 5 (0.9%) 2 (0.4%) 6 (1.1%) 2 (0.4%) 2 (0.4%) 3 (0.5%) 4 (0.7%) 5 (0.9%) 2 (0.4%) 3 (0.5%) Notes: 1NOS = Not otherwise specified. Saline N = 296 204 (68.9%) 0 (0%) 1 (0.3%) 6 (2.0%) 2 (0.7%) 11 (3.7%) 51 (17.2%) 5 (1.7%) 3 (1.0%) 2 (0.7%) 6 (2.0%) 0 (0%) 1 (0.3%) 2 (0.7%) 2 (0.7%) 1 (0.3%) 0 (0%) 2 (0.7%) Arthrocentesis N = 123 65 (52.8%) 0 (0%) 0 (0%) 1 (0.8%) 1 (0.8%) 1 (0.8%) 1 (0.8%) 0 (0%) 0 (0%) 0 (0%) 2 (1.6%) 0 (0%) 1 (0.8%) 0 (0%) 1 (0.8%) 1 (0.8%) 1 (0.8%) 0 (0%) Table 3 Baseline and patient demographics summary—effectiveness subgroup.1 Characteristic No. (%) female Mean ± SD age (years) Mean ± SD BMI (kg/m2) Mean ± SD WOMAC Pain (0-500 mm) Study Knee Mean ± SD WOMAC Pain (0-500 mm) Contralateral Mean ± SD Investigator Global (0-100 mm) Mean ± SD Patient Global (0-100 mm) O3 N = 83 51 (61.4%) 65 ± 8 32 ± 7 274 ± 65 Saline x 3 N = 81 49 (60.5%) 68 ± 9 30 ± 6 268 ± 70 O4 N = 104 46 (44.2%) 59 ± 9 29 ± 4 288 ± 60 O3A1 N = 90 59 (65.5%) 59 ± 9 30 ± 4 290 ± 50 A4 N = 100 50 (50.0%) 59 ± 8 30 ± 4 293 ± 59 83 ± 57 87 ± 54 69 ± 47 70 ± 47 68 ± 48 53 ± 19 51 ± 19 59 ± 14 58 ± 14 58 ± 15 56 ± 20 53 ± 22 67 ± 15 62 ± 17 64 ± 15 Notes: 1Patients with Kellgren-Lawrence radiographic grades of II or III at baseline and WOMAC pain in the contralateral knee of <175mm (out of 500). Combined Study Results In the combined analysis of OAK9501 and OAK2001, two subgroup populations (representing patients with baseline Kellgren-Lawrence grade II or III radiographic findings and contralateral knee pain <175 mm on the WOMAC Pain Score) were analyzed together, comprising 5 treatment groups (4 ORTHOVISC® injections [O4], ORTHOVISC® High Molecular Weight Hyaluronan ORTHOVISC® High Molecular Weight Hyaluronan 3 ORTHOVISC injections followed by 1 arthrocentesis [O3A1], 3 ORTHOVISC injections [O3], 4 arthrocentesis procedures [A4] and 3 saline injections [Saline]). For the GEE analyses, the O3A1 and O3 groups were also pooled to form a sixth group [O3A1/O3]. Summary In summary, with respect to patients achieving 40% and 50% improvement in WOMAC Pain Score compared to baseline, the four injection ORTHOVISC® regimen demonstrated effectiveness compared to both Saline and Arthrocentesis control procedures, and the three-weekly injection regimen demonstrated effectiveness compared to Saline in the indicated patient population. ® ® The primary effectiveness analysis was performed to determine the proportion of patients achieving a 20% improvement from baseline in the WOMAC Pain Score in conjunction with a minimum absolute improvement of 50 mm from baseline in the WOMAC Pain Score, and a 40% and 50% improvement from baseline in WOMAC Pain Score at four assessment points between Weeks 7/8 to 21/22 for the index knee. A significantly larger proportion of O4 patients achieved 40% and 50% improvements from baseline in WOMAC Pain Score compared to both A4 and Saline over 7-22 weeks (based on GEE analysis). Similarly, a significantly larger proportion of O3 and O3A1/O3 patients achieved 40% and 50% improvements from baseline in WOMAC Pain Score than Saline patients (based on GEE analysis) (Table 4). Table 5 presents the mean number of patients from the effectiveness subgroup over the four follow-up visits that achieved improvement over weeks 7 through 22. Table 4 GEE Results (P-Values) for the Effectiveness Subgroups for the Primary Endpoints Endpoint O4 vs. A4 20% improvement from baseline and 50 mm absolute improvement in WOMAC Pain 40% improvement in WOMAC Pain Score from baseline 50% improvement in WOMAC Pain Score from baseline 0.0738 O4 vs. Saline 0.1116 O3 vs. Saline 0.0789 0.0094* 0.0015* 0.0166* 0.0360* 0.0015* 0.0274* DETAILED DEVICE DESCRIPTION Hyaluronan is a high molecular weight polysaccharide composed of repeating disaccharide units of sodium glucuronate and N-acetylglucosamine. Each syringe contains the following in a 2 mL dose sterile-filled into a syringe: Hyaluronan 30 mg Sodium Chloride 18 mg Water for Injection q.s. up to 2.0 mL ORTHOVISC® does not contain any synthetic additives. HOW SUPPLIED ORTHOVISC® is supplied as a sterile-filled solution, in a single-use syringe, sealed in a sterile pouch inside a carton. The product is presented as a sterile, non-pyrogenic solution in a 3 mL syringe. Each syringe is labeled “ORTHOVISC®” for ready identification. A rubber cap is provided on the syringe tip to prevent leakage and protect sterility of the product. The ORTHOVISC® syringe components contain no latex. DIRECTIONS FOR USE ORTHOVISC® is injected into the knee joint in a series of intra-articular injections one week apart for a total of three or four injections. Standard intra-articular injection site preparation, aseptic technique and precautions should be used. Do not concomitantly use disinfectants containing quarternary ammonium salts for skin preparation as hyaluronic acid can precipitate in their presence. O4 4 weekly ORTHOVISC injections—OAK2001 Study O3 3 weekly ORTHOVISC® injections—OAK9501 Study A4 4 control [arthrocentesis only] procedures—OAK2001 Study Saline 3 control [saline injection] procedures—OAK9501 Study *Statistically significant ® • After removal of the protective rubber cap on the tip of the syringe, securely attach a small gauge needle (18-21 gauge) to the tip. • Inject ORTHOVISC® into the knee joint using proper injection technique. • Inject the full contents of the syringe into one knee only. • If treatment is bilateral, a separate syringe should be used for each knee. • If symptoms return, repeat courses of ORTHOVISC® may be administered. Table 5 Summary of mean number patients achieving primary individual patient success criteria— effectiveness subgroups from OAK9501 and OAK2001—over weeks 7 through 22 (4 visits). Endpoint Mean No. (%) patients achieving 20% improvement from baseline and absolute improvement of 50 mm in WOMAC Pain Mean No. (%) patients achieving 40% improvement from baseline in WOMAC Pain Mean No. (%) patients achieving 50% improvement from baseline in WOMAC Pain O4 O3A1 O3 A4 Saline O4 N = 104 77.5 (74.5%) O3A1 N = 90 58.3 (64.7%) A4 N = 100 64.5 (64.5%) O3 N = 83 59.3 (71.4%) ORTHOVISC® is a registered trademark of Anika Therapeutics, Inc. Saline x 3 N = 81 50.8 (62.7%) 68.0 (65.4%) 47.0 (52.2%) 48.8 (48.8%) 45.8 (55.1%) 34.3 (42.3%) 59.3 (57.0%) 40.5 (45.0%) 43.5 (43.5%) 38.5 (46.4%) 28.3 (34.9%) Manufactured by: Anika Therapeutics, Inc. 236 West Cummings Park Woburn, MA USA 01801 Distributed by: DePuy Mitek, Inc. 325 Paramount Drive Raynham, MA 02767 DePuy Mitek, Inc. NDCParamount code: 59676-0360-01 325 Drive Product Code: 277500 Raynham, MA 02767 530-220 AML 06/05 NDC code: 59676-0360-01 Product Code: 277500 4 weekly ORTHOVISC® injections—OAK2001 Study 3 weekly ORTHOVISC® injections + 1 control [arthrocentesis only] procedure—OAK2001 Study 3 weekly ORTHOVISC® injections—OAK9501 Study 4 control [arthrocentesis only] procedures—OAK2001 Study 3 control [saline injection] procedures—OAK9501 Study Hyalgan is a registered trademark of sanofi-synthelabo; Supartz is a registered trademark of Seikagaku Corporation; Synvisc is a registered trademark of Genzyme Corporation; Euflexxa is a trademark of Ferring Pharmaceuticals, Inc. References: 1. Adams ME, Lussier AJ, Peyron JG. A risk-benefit assessment of injections of hyaluronan and its derivatives in the treatment of osteoarthritis of the knee. Drug Saf. 2000;23(2):115-130. 2. Mazzucco D, McKinley G, Scott RD, Spector M. Rheology of joint fluid in total knee arthroplasty patients. J Orthop Res. 2002;20(6):1157-1163. 3. Adams ME. Viscosupplementation as articular therapy. In: Laurent TC, ed. The Chemistry, Biology and Medical Applications of Hyaluronan and its Derivatives. London, England: Portland Press Ltd.; 1998:244-253. 4. Orthovisc (high molecular weight hyaluronan) manufacturer’s full prescribing information. 5. Synvisc (hylan G-F 20) manufacturer’s full prescribing information. 6. Balazs EA, Denlinger JL. Viscosupplementation: a new concept in the treatment of osteoarthritis. J Rheumatol. 1993;20(suppl 39):3-9. 7. Wobig M, Bach G, Beks P, et al.The role of elastoviscosity in the efficacy of viscosupplementation for osteoarthritis of the knee: a comparison of Hylan G-F 20 and lower-molecularweight hyaluronan. Clin Ther. 1999;21(9):1549-1561. 8. Moreland LW. Intra-articular hyaluronan (hyaluronic acid) and hylans for the treatment of osteoarthritis: mechanisms of action. Arthritis Res Ther. 2003;5(2):54-67. 9. Hyalgan (sodium hyaluronate) manufacturer’s full prescribing information. 10. Supartz (sodium hyaluronate) manufacturer’s full prescribing information. 11. Euflexxa™(1% sodium hyaluronate) manufacturer’s full prescribing information. 12. Data on file, DePuy Mitek, Inc., Raynham, MA. 13. Goldberg VM, Coutts RD. Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment. Clin Orthop Relat Res. 2004;419:130-137. 14. Brandt KD, Block JA, Michalski JP, Moreland LW, Caldwell JR, Lavin PT; for the ORTHOVISC Study Group. Efficacy and safety of intraarticular sodium hyaluronate in knee osteoarthritis. Clin Orthop. 2001;385:130-143. 15. American Academy of Orthopaedic Surgeons. Knee osteoarthritis—Phase II. http://www.aaos.org/wordhtml/research/guidelin/chart_oakn2.pdf. Accessed February 27, 2006. 16. American College of Rheumatology. Recommendations for the medical management of osteoarthritis of the hip and knee. http://www.rheumatology.org/publications/guidelines/oa-mgmt/oa-mgmt.asp. Accessed February 27, 2006. ® ® ® ® Match what exists. It’s only natural. • Only non-avian HA with proven efficacy across 26 weeks13 • Highest HA concentration among viscosupplements3,5,6,7,8,9 • Closely matches healthy synovial fluid • Provides significant improvement in WOMAC pain score versus saline at all time points13 • Up to 6 months of symptom relief with 3 or 4 injections Don’t wait, treat early. For additional information, please call your DePuy Mitek Sales Representative at 1-800-382-4682 or visit us at www.orthoviscline.com. AN OFFICIAL HEALTH AND FITNESS PROVIDER AN OFFICIAL HEALTH AND FITNESS PROVIDER References: 1. Mazzucco D, McKinley G, Scott RD, et al. Rheology of joint fluid in total knee arthroplasty patients. J Orthop Res. 2002;20(6): 1157-1163. 2. Adams ME. Viscosupplementation as articular therapy. In: Laurent TC, ed. The Chemistry, Biology and Medical Applications of Hyaluronan and its Derivatives. London, England: Portland Press Ltd.; 1998:244-253. 3. ORTHOVISC® (high molecular weight hyaluronan) manufacturer’s full prescribing information. 4. Adams ME, Lussier AJ, Peyron JG. A risk-benefit assessment of injections of hyaluronan and it’s derivatives in the treatment of osteoarthritis of the knee. Drug Saf. 2000;23(2):114-130. 5. Synvisc® (hylan G-F 20) manufacturer’s full prescribing information. 6. Synvisc-One® (hylan G-F 20) manufacturer’s full prescribing information. 7. Hyalgan® (sodium hyaluronate) manufacturer’s full prescribing information. 8. Supartz® (sodium hyalronate) manufacturer’s full prescribing information. 9. Euflexxa TM (1% sodium hyaluronate) manufacturer’s full prescribing information. 10. Ghosh Peter, Guidolin Diego. Potential Mechanism of Action of Intra-articular Hyaluronan Therapy in Osteoarthritis: Are the Effects Molecular Weight Dependent? Seminars in Arthritis and Rheumatism. 2002 ; 32:10-37. 11. Data on file. DePuy Mitek, Inc., Raynham, MA. 12. Goldberg VM, Coutts RD. Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment. Clin Orthop Relat Res. 2004;419:130-137. 13. Brandt KD, Block JA, Michalski JP, et al. Efficacy and safety of intraarticular sodium hyaluronate in knee osteoarthritis. Clin Orthop Relat Res. 2001;385:130-143. 14. American College of Rheumatology. Recommendations for the medical management of osteoarthritis of the hip and knee. http://www.rheumatology.org/publications/guidelines/oa-mgmt/oa-mgmt.asp. Accessed Feb 3rd, 2010. Hyalgan is a registered trademark of Sanofi-Synthelabo; Supartz is a registered trademark of Seikagaku Corporation; Synvisc and Synvisc-One are registered trademarks of Genzyme Corporation; Euflexxa is a trademark of Ferring Pharmaceuticals, Inc. ORTHOVISC is a registered trademark of Anika Therapeutics. Manufactured by Anika Therapeutics Anika Therapeutics, Inc. Bedford, MA 01730 USA DePuy Mitek, Inc. 325 Paramount Drive Raynham, MA 02767 P/N 900878 Rev. A 4/10 © DePuy Mitek, Inc. 2010. All rights reserved. Printed in USA.
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.4 Linearized : Yes XMP Toolkit : Adobe XMP Core 4.0-c321 44.398116, Tue Aug 04 2009 14:24:39 Instance ID : uuid:dd31f2b1-9acd-4ca1-ac4d-5109b0407773 Document ID : adobe:docid:indd:418be80f-5aab-11df-a74a-927150fa996a Rendition Class : proof:pdf Derived From Instance ID : 1b007b11-59df-11df-9378-992654968a5b Derived From Document ID : adobe:docid:indd:0abcf3d5-5539-11df-bdef-c4a0318c6992 Manifest Link Form : ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream Manifest Placed X Resolution : 266.00, 72.00, 72.00, 300.00, 300.00, 300.00, 72.00, 300.00, 300.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00 Manifest Placed Y Resolution : 266.00, 72.00, 72.00, 300.00, 300.00, 300.00, 72.00, 300.00, 300.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00 Manifest Placed Resolution Unit : Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches Manifest Reference Instance ID : xmp.iid:9F2D013B8D216811AB08CCEB106682D0, uuid:B41AFC94CDC211DD9AABA83BAACF3AE7, uuid:1AD63C26B1F3DD11BBC9A706CFCA9913, xmp.iid:9E2D013B8D216811AB08CCEB106682D0, xmp.iid:9E2D013B8D216811AB08CCEB106682D0, xmp.iid:9E2D013B8D216811AB08CCEB106682D0, uuid:1E9811C7AF5ADF11BC83A523C9CD3F4D, uuid:8AE35D862359DF11B247D0023A4E3130, uuid:8AE35D862359DF11B247D0023A4E3130, uuid:f8993cbd-adb1-1c4f-92f1-b869e1daa1cd, uuid:b269bd79-a8dc-2740-b166-05afe340d1e2, uuid:677FDF3FB2F3DD11BBC9A706CFCA9913, uuid:B41AFC94CDC211DD9AABA83BAACF3AE7, uuid:1AD63C26B1F3DD11BBC9A706CFCA9913, uuid:DD9B1260001311DE98F9A2D28684763D, uuid:DD9B1260001311DE98F9A2D28684763D Manifest Reference Document ID : xmp.did:589E36A8DA2068119C8283451001F67A, uuid:B41AFC93CDC211DD9AABA83BAACF3AE7, uuid:AB42C0E8DC1511DDB51EFDACCFEAD551, xmp.did:9D2D013B8D216811AB08CCEB106682D0, xmp.did:9D2D013B8D216811AB08CCEB106682D0, xmp.did:9D2D013B8D216811AB08CCEB106682D0, uuid:756BC5C29639DF119A288A708C0C240D, uuid:89E35D862359DF11B247D0023A4E3130, uuid:89E35D862359DF11B247D0023A4E3130, uuid:1c8154f4-005b-7347-aacd-b3f9a63a9546, uuid:1c8154f4-005b-7347-aacd-b3f9a63a9546, uuid:5D4749D7DC1B11DDB51EFDACCFEAD551, uuid:B41AFC93CDC211DD9AABA83BAACF3AE7, uuid:AB42C0E8DC1511DDB51EFDACCFEAD551, uuid:DD9B125F001311DE98F9A2D28684763D, uuid:DD9B125F001311DE98F9A2D28684763D Create Date : 2010:05:06 19:15:23-04:00 Modify Date : 2010:05:14 13:04:03-04:00 Metadata Date : 2010:05:14 13:04:03-04:00 Creator Tool : Adobe InDesign CS3 (5.0.4) Thumbnail Format : JPEG Thumbnail Width : 256 Thumbnail Height : 256 Thumbnail Image : (Binary data 11626 bytes, use -b option to extract) Format : application/pdf Producer : Adobe PDF Library 8.0 Trapped : False Page Count : 8 Creator : Adobe InDesign CS3 (5.0.4)EXIF Metadata provided by EXIF.tools