The intra-articular gel implant containing sterile, absorbable hyaluronic acid is a low-high molecular weight polysaccharide. It contains sodium hyaluronate, sodium glucuronate, N-acetylglucosamine, sodium chloride and purified water. Hyaluronic acid is a natural component found in all body tissues and is particularly highly concentrated in tissues such as vitreous fluid, synovial fluid, umbilical cord and dermis. Acting as a tissue lubricant, hyaluronic acid regulates interactions between adjacent tissues and helps to separate tissues by providing viscoelastic support.

This implant is an invasive medical device that provides intra-articular support without interfering with normal wound healing processes.

Chemical and Physical Components

Buffer Agents

• Sodium dihydrogen phosphate
• Disodium hydrogen phosphate
• L-Proline

Other Ingredients

• Sodium hyaluronate (linearly bound)
• Glass pre-filled injector system (Luerlock & end cap)
• Medical Tyvek
• Medical PET
• Cardboard box and labeling

Warnings and Precautions

• The product is for single use only and must not be reused.
• Reprocessing (cleaning, sterilization) may compromise the integrity of the product and cause serious health problems for the patient.
• Implants contaminated with blood, tissue or body fluids must not be reused.
• Injection should only be performed by medical professionals familiar with intra-articular injection techniques.
• Excessive amounts of sodium hyaluronate should not be used.
• The joint cavity should not be overfilled.
• If pain occurs during injection, the procedure should be stopped immediately and the needle withdrawn.
• Used syringes, needles and remaining products should be disposed of in accordance with local legislation.

Sterilization Knowledge

The product has been sterilized by moist heat sterilization. This method has been validated according to ISO 17665-1:2006.

Mechanism and Biological Destruction of Hyaluronic Acid

Hyaluronic acid is a biopolymer that resembles the natural viscous properties of healthy synovial fluid. Studies show that hyaluronic acid implants undergo little biodegradation when injected subdermally. It is slowly absorbed by macrophages around the capsule formation locally.

Hyaluronic acid has been found to remain biologically active in the body for between 2 and 10 years. Studies show that hyaluronic acid decomposes into low molecular weight components and is excreted through the kidneys. Experiments on rabbits have shown that injected hyaluronic acid maintains its homogeneous structure for the first 1-3 days, partial lysis begins on the 7th day and is completed within 3-6 months. In the human body, this process is estimated to take up to 21 months.

Differences from Standard Hyaluronic Acid Visco-supplements

This intra-articular hyaluronic acid implant gel is intended for use in the treatment of cartilage damage due to osteoarthritis (OA), degenerative joint diseases (DJD), meniscopathy and synovial fluid deficiency. The product is fortified with L-Proline and helps to reduce degeneration by increasing collagen synthesis in the cartilage matrix.

What is L-Proline?

L-Proline is a natural amino acid that is abundant in collagen. When taken as a supplement, it provides the necessary raw materials for collagen synthesis in the body. L-Proline has clinically proven anti-inflammatory and anti-rheumatic effects on osteoarthritis, rheumatic diseases and joint pain. In particular, it helps relieve symptoms such as osteoarthritis, pain in joint movement, swelling and loss of function.

Treatment Process

This formulation was developed as an intra-articular injection matrix gel containing high purity sodium hyaluronate and L-Proline. Clinical studies show that the L-Proline supplemented hyaluronic acid formula is more effective than hyaluronic acid-only formulations. It provides long-term cartilage protection by supporting collagen production and promotes the survival of cartilage cells.

Why This Product?

• Made with ultra-pure ingredients and safe handling technology.
• Completely free of particles (by 0.22 µm gel filtration).
• It is not just a visco-supplementation, but a medical device fortified with L-Proline.

This hyaluronic acid gel provides long-term joint protection and offers an effective treatment option for osteoarthritis and degenerative joint diseases.