Ha Gel Filler for Intra-Articular bulk in bottle

Ha Gel Filler for Intra-Articular bulk in bottle

Hyaluronic acid (HA) is a very important component of the articular cartilage and has a significant role in maintaining the articular homeostasis. The concentration of HA in the synovial fluid of human knee is about 2.5-4.0 mg/ml in normal conditions. In patients suffering from rheumatoid arthritis (RA) or osteoarthritis (OA) its concentration is halved. HA contributes to the lubrication of the articulation, shock absorption and nutrition for the articular tissue. In pathological conditions, there is a reduction of the HA synthesis by the synoviocytes and the production of a form of HA which is not able to guarantee the metabolic balance with consequent impact on the articulation. The substitution of the damaged fluid with an intra-articular injection of HA having the same properties of the original synovial fluid is able to restore the physiological conditions of the joint.

PRODUCT CHARACTERISTICS:
Is a medical device constituted by a physiological solution of sodium hyaluronate (NaHA) in sterile syringe for intra-articular injections ready to use.

Sodium hyaluronate is obtained by bio-fermentation (Streptococcus of Lancefields group A and C)
Throughout high purification processes which ensure a final product with a defined molecular weight (800-1200 KDalton).

Is totally free from the animal proteins occurring in the extractive materials.

Is indicated in case of replacement and/or complementing of synovial fluid damaged following degenerative or traumatic origin diseases of the articulation.

Results in a marked pain reduction, improvement of the articular mobility, decreased use of rescue medication.
  The effects Are already evident starting from the 1st injection (out of a cycle of 3 to 5) and last up to 6 months, suggesting a long-lasting carry-over effect of the treatment. 

Is available in the following ready-to-use formulations:
  0.8% (16mg HA in 2mL) for an effective
And well tolerated viscosupplementation in knee OA and other conditions.
  1.6% (32mg HA in 2mL) indicated
Especially for those conditions when a major joint lubrication and an attack therapy in OA are needed.
   Mini, a 0.8% physiological solution of sodium hyaluronate at a low volume (8mg HA in
1mL), in case of infiltration of little joints (e. G. Rhizarthrosis, tenosynovitis, trigger finger).

MAIN DIFFERENTIATING POINTS FROM OTHER HA
A) Molecular weight
1) Low-to-MID molecular weight (MW) hyaluronic acids which consist in long unbranched chains of natural hyaluronan, not chemically modified. Products belonging to this category are ie:
(MW=800-1200 kDa); Hyalgan® (MW=500-730 kDa). 

Evidences from large animal models of OA show that HAs with MW between 500-1000 KDa are more effective than high MW HAs in reducing synovial inflammation and for the restoration of the rheological properties of synovial fluid (the so-called viscosupplementation effect). 8, 9 2) High molecular weight hylans which consist in chemically modified cross-linked hyaluronan chains. A product belonging to this category is ie: Synvisc® (MW=6000 kDa).

B) Viscoinduction
The long-lasting effect compared to the relatively short half-life of intra-articular hyaluronic acid may be explained by its CD44-mediated metabolic modulation.

The viscoinduction effect of HA may by far exceed that of the lubricant effect and represents a most advanced explanation of the mechanism of action of HA with low-to-MID MW.

C) Source of hyaluronan
Is obtained by biofermentation, which ensures that the product is pure and free of potentially allergenic animal proteins. Other HAs/hylans are
Obtained by extraction from rooster combs with a potential increased risk of immunogenicity due to the presence of avian proteins.