ARTHROMAC A A n e n w e g e g ne n ra r t a i t o i n of f v is i c s o c su s p u p p l p e l me m nt n s t

Transkript

1 ARTHROMAC A new generation of viscosupplements

2 Viscosupplementation In the arthritic joint, the normal concentration and molecular weight of hyaluronate(ha) is decreased by 33% to 50%, limiting its role in maintaining normal joint biomechanics Purpose of viscosupplementation: replace this lost HA

3 Effects: Joint lubrication; Anti-inflammatory effects; Analgesic effects; Chondro-protective effect.

4 Clinical results: Pain relief; Mobility improvement; Cartilage protection.

5 Nature of the action: Biological action (not mechanical): ExogenousHA stands only few hoursin the joint; Exogenous HA stimulates the production of endogenous HA within the joint.

6 History: First studies in the 60s on horses and in the 70s on humans First commercially available forms with HA from rooster combs. Primarily used in veterinary practice in the United States until 1997 when Synvisc (hylan G-F 20) and Hyalgan were approved as medical devices by the Food and Drug Administration. Followed by the development of several other products with varying molecular weights and purity, and from HA of nonanimal origin (bacterial fermentation).

7 Treatmentcourses: 3 to 5 injections a week apart; Since few years, visco-supplements Since few years, visco-supplements administered by mono-injection appeared (Synvisc-One, Durolane, Monovisc, Arthromac ).

8 Alternative treatments Nonsteroidal anti-inflammatory drugs (NSAIDs): significant side effects and are not well tolerated by all patients; cardiovascular risk; gastrointestinal adverse effects; risk of developing significantulcer disease while taking even a short course (6 days to 2 weeks)of NSAIDs is 16% to 22%; 44% of patients candevelop significant dyspepsia, requiring additional medical treatment. Corticosteroid injections: risk of advancing articular cartilage degradation.

9 VS advantages: Safety: Drug-free, very low adverse events; Effectiveness: Numerous clinical studies show that at 6-month follow-up, exogenous HA injection provided superiorpain relief and functional improvement compared with placebo, oral NSAIDs and corticosteroid injections; Disease-modifyingeffect: NSAIDs and corticosteroid injections treat only the symptom of pain by antiinflammatory effects. They do not treat the cause of the disease. VS provides also a protection against the progression of structural cartilage degeneration.

10 Ideal patient: For maximum benefit, VS early in thetreatment of their disease. Patients older than 65 years of age withmore advanced degenerative disease were less likely to respond toha treatment than were their younger counterparts with less severe OA. Why? To take advantage ofthe anti-inflammatory, anabolic, and chondroprotective effects ofha at a stage at which the overall course of the disease may beslowed or even modified. By stimulating endogenous HA productionby synoviocytes, absorbing inflammatory cytokines, andinhibiting degenerative changes within chondrocytes and thecartilage matrix, supplementation in a younger, less symptomaticpatient population may have significant longer-term benefits.

11 Injection: the affected kneeis first aspirated to remove any effusion that may be present,decreasing the concentration of inflammatory mediators that may be present and limiting the dilutionaleffect the effusion would have on the injected material superolateralor lateral midpatellarinjection site is the most reliablefor reaching the synovial joint space of the knee

12 Additional indications: Postarthroscopy; Following meniscal repair; Following anterior cruciate ligament reconstruction; Adjunctive treatment for patients with osteochondral defects; Postmosaicplasty; Patients with isolated patellofemoral pain.

13 ARTHROMAC Competitive advantages: Only one injection. The single injection regimen reduces patient inconvenience. HA of very high purity (less than 0,05 % of proteins and less than 0,0015 IU/mg of endotoxins) HA of non-animal origin.arthromac is manufactured from a HA obtained by biofermentation Entirely natural. ARTHROMAC does not contain any toxic cross-linking agents such as BDDE, formaldehyde, dicinyl sulfone etc. The natural cross-linking technology provides non-toxicity and high biocompatibility and avoid hypersensitivityreaction

14 ARTHROMAC Competitive advantages: Optimal HA molecular weight (3 Million Dalton after sterilization) and concentration (20 mg/ml) according to external and internal clinical data Approved for all synovial joints (particularly the knee and hip, but also the ankle, shoulder, elbow, wrist, fingers, toes, and the temporomandibular and facet joints) Proprietary sterilization process protecting HA from damage and providing optimal viscoelastic properties.

15 ARTHROMAC+ Additionalcompetitiveadvantages The first and alone commercial viscosupplement combining HA and CS (Chondroitin Sulphate) The adjunction of CS provides not only pain relief, mobility improvement and cartilage protection, but also cartilage regeneration. This cartilage repair is particularly useful in severe OA (grade III and IV).

16 Durationof effect: The beneficial effects of ARTHROMAC can last up to a year. The durability varies from several months to a year depending on : - the patient s condition and age; - patient s lifestyle; -the severity of the disorder to be treated; -the type of joint affected; - the volume injected. After the injection, an articular rest of approximately 24 hours is recommended (no strenuous exercise) in order to augment the duration of effect.

17 Adverse events: Following injection, transient pain and swelling of the injected joint may occur. These temporary reactions which generally subside over 72 hours do not have to be the source of concern and can be simply treated by resting and applying ice to the injected joint.

18 THANK YOU CONTACT: IULIA DOBRE Sales Manager Biomaterials Division ORTOBRAND Address: 7 Erou Dumitru Vlăsceanu Str., Pipera Voluntari, Ilfov County, Romania Tel dental@ortobrand.ro Skype: iulia-dobre