ARTHROMAC® 3%

30

MONOVISC

22

DUROLANE

SYNVISC-ONE

10

GEL-ONE

8

Co

ncen

trati

on

of

HA

(m

g/m

l)

35

30

25

20

15

10

5

0

20

A single injection.A long-term pain relief.

Professional Information

The highest concentration.

The specific network system applied in ARTHROMAC®3% enables to increase the concentration of HA to optimal levels. The number of molecules of HA decreases with age6 and is an essential factor in the biological response in terms of cellular stimulation as well as a crucial parameter for the rheological properties of the gel7. ARTHROMAC®3% provides 30 mg/ml of HA in a  3  ml syringe which corresponds to the highest HA concentration and the highest HA content per injection on the market. 

6. Longas MO, Russell CS, He XY. Evidence for structural changes in dermatan sulfate and hyaluronic acid with aging. Carbohydr Res. 1987 Jan 15;159(1):127-36.

7. Wendy E. Krause, Enrico G. Bellomo, and Ralph H. Colby. Rheology of Sodium Hyaluronate under Physiological Conditions. Biomacromolecules 2001, 2, 65-69.

This graph compares the HA concentration, the HA source and the type of cross-linking between ARTHROMAC®3% and the other leading single injection viscosupplements.

For more information, visit www.arthromac.com

Physical cross-linking

Chemical cross-linking

Non-animal origin

Animal origin

ARTHROMAC 3% is a CE-marked medical device.Copyright © 2015 Novatex Bioengineering.

Date of preparation: September 2015

www.arthromac.com

While most of the products for viscosupplementation on the market need 3 to 5 injections per treatment cycle, ARTHROMAC®3%, thanks to its high content of hyaluronic acid (HA) and its cross-linking process that extend the residence time of the gel in the joint, requires only a single injection, which strongly reduces patient inconvenience.

No animal origin

ARTHROMAC®3% is manufactured from a HA of non-animal origin obtained by biofermentation. Other viscosupplements, even some of the leading brands, use avian sourced HA (from cock’s comb) which is less expensive but which also has a high animal protein content, leading to possible allergic reactions and a higher rate of adverse events. Clinical studies comparing animal and non-animal HAs confirmed that significantly greater number of adverse events was observed in animal HA-treated patients 1, 2. Today, biofermentation is the HA source of choice due  to the high purity, viscosity and non-animal advantages.

No toxic agent

Thanks to a proprietary technology,  ARTHROMAC®3% is made from a physically cross-linked hyaluronic acid and does not contain any toxic cross-linking substances such as 1,4-butanediol diglycidyl ether (BDDE), formaldehyde, divinyl sulfone etc. which are used by numerous competitors 3-5. This unique non-toxic cross-linking process makes it possible to provide a better resistance to mechanical, enzymatic, oxidative and thermal degradations, but also a higher power of synoviocyte and chondrocyte stimulation, thus combining the advantages of a chemically crosslinked HA and a linear HA. The result is a fully biocompatible single injection product and a significant and long-lasting pain relief for the patient.

NOVATEX BIOENGINEERING4, rue de l’Amiral Courbet75116 Paris - France

1. Robert J Petrella Anthony cogliano Joseph Decaria. Comparison of avian and nonavian hyaluronic acid in osteoarthritis of the knee. Orthopedic Research and Reviews 2010:2 5–9.

2.  Jüni P,  Reichenbach S,  Trelle S,  Tschannen B,  Wandel S,  Jordi B,  Züllig M, Guetg R, Häuselmann HJ, Schwarz H, Theiler R, Ziswiler HR, Dieppe PA,  Villiger PM,  Egger M.  Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial.Arthritis Rheum. 2007 Nov;56(11):3610-9.

3. West JD, Stamm CE, Brown HA, Justice SL, Morano KA. Enhanced toxicity of the protein cross-linkers divinyl sulfone and diethyl acetylenedicarboxylate in comparison to related monofunctional electrophiles. Chem Res Toxicol. 2011 Sep 19;24(9):1457-9. doi: 10.1021/tx200302w. Epub 2011 Aug 8.

4. Cancer risk assessment P020023 www.fda.gov

5. National Toxicology Program (June 2011). Report on Carcinogens, Twelfth Edition. Department of Health and Human Services, Public Health Service, National Toxicology Program. Retrieved June 10, 2011.

COMPOSITION

HA CONCENTRATION

HA ORIGIN

HA MOLECULAR WEIGHT

INDICATION

EFFECTS

DURATION OF EFFECTS

ADMINISTRATION

PACKAGING

STERILIZATION

SHELF LIFE

STORAGE

ARTHROMAC®3%

SODIUM HYALURONATE

30 MG/ML

BIOFERMENTATION

3 MDA IN THE STERILIZED PRODUCT

MILD-TO-SEVERE OA

PAIN RELIEF, MOBILITY IMPROVEMENT, CARTILAGE PROTECTION

UP TO 12 MONTHS*

SINGLE INTRAARTICULAR INJECTION

STERILE 3 ML GLASS SYRINGE

AUTOCLAVE

3 YEARS

BETWEEN +2°C and +25°C

* Depending on several factors such as the severity of the osteoarthritis, the type and size of the affected joint, the patient’s condition and age and the patient’s lifestyle.