Flexotron^® (Implant) Instructions for Use

Therapeutic Category

Medical device for the treatment of musculoskeletal system diseases

Properties

Flexotron^® Smart is a synovial fluid prosthesis containing sodium hyaluronate, obtained by bacterial fermentation, in a phosphate buffer.

It is intended for viscoelastic supplementation of synovial fluid in patients with degenerative-dystrophic and post-traumatic joint lesions, as well as in individuals with increased stress on damaged joints.

Hyaluronic acid is a poly-(2-acetamido-2-deoxy-D-gluco)-D-glucuronoglycan, i.e., a polymer consisting of D-glucuronic acid and N-acetyl-D-glucosamine residues alternately linked by β-1,4- and β-1,3-glycosidic bonds. Due to this polymeric three-dimensional structure, large negatively charged aggregates are formed that hold water. These aggregates are responsible for the moisture content, resilience, and elasticity of the cartilage tissue (its resistance to compression).

Intra-articular enrichment of synovial fluid with sodium hyaluronate injections contributes to the improvement or restoration of the viscoelastic properties of natural synovial fluid. Sodium hyaluronate is responsible for the viscoelastic properties of synovial fluid; thus, viscoelastic supplementation compensates for the deficiency of hyaluronic acid in the synovial fluid or the decrease in its viscosity, mitigates external loads on the joint, provides lubrication, restoration of elasticity and viscosity, shock absorption, hydration, and coating of the joint surfaces, covering the cartilage and synovial receptors with a lubricating protective layer. This helps to increase the range of motion and provides mechanical protection for the tissues of the joint cavity, which in turn can improve the course of osteoarthritis/osteoarthritis and other degenerative-dystrophic and post-traumatic joint pathologies.

Based on clinical data on the features of biodegradation and the duration of therapeutic effects of intra-articular administration of hyaluronic acid, it is assumed that the biodegradation of the Flexotron^® viscoelastic implant occurs within 12 to 24 weeks. The clinical effect of treatment persists for at least 6 months.

The implant does not contain a medicinal product for medical use, materials of animal and/or human origin.

Biodegradation

Hyaluronic acid is cleaved by a family of enzymes called hyaluronidases, most of which are lysosomal, forming monomeric non-toxic degradation products (the primary degradation products are oligosaccharides and low molecular weight hyaluronates). There are at least seven types of hyaluronidase-like enzymes in the human body. The rate of biodegradation depends on the condition and metabolic characteristics of the particular patient. Degradation of high molecular weight extracellular hyaluronate occurs as a series of separate steps, generating hyaluronic chains of decreasing size. There is no data on the negative impact of degradation products on the implant or any of their systemic effects in the human body. Some degradation products can be used in the processes of endogenous re-synthesis.

Scope of Application

Of the Flexotron^® Smart product

• Osteoarthritis/osteoarthrosis and other degenerative-dystrophic and post-traumatic lesions of the knee, hip, and other synovial joints;
• Restoration of synovial fluid properties in orthopedic joint surgery, as well as in individuals with increased stress on damaged joints.

ICD codes

Dosage Regimen

Implant

The administration of the product must be performed under aseptic conditions in procedure and manipulation rooms by healthcare professionals proficient in the technique of intra-articular injections.

The volume of one implant is close to the safe volume for medium and large joints of an adult. There are no restrictions regarding the anthropometric and anatomical characteristics of the target patient.

The prefilled 2 ml syringe is intended for the treatment of the knee, hip, shoulder, and ankle joints. Simultaneous treatment of several joints is possible.

For a treatment cycle, it is recommended weekly; 1 injection per week for 1-3 weeks. The cycle can be repeated after several months (depending on individual condition).

Repeated treatment cycles are allowed.

Method of administration

Injections are performed by specialist doctors under aseptic conditions.

Before administering the implant, the contents of the syringe should be visually assessed for clarity and homogeneity. Cloudiness, crystallization, the appearance of color and/or foreign inclusions may indicate a violation of the transportation and storage rules of the product. If the above signs appear, administration of the implant is prohibited.

Remove the cap from the Luer tip of the prefilled syringe and screw the corresponding sterile needle with a sharp tip onto the tip.

For injection, it is necessary to use disposable sterile needles size 21G (not included in the delivery set).

It is necessary to disinfect the skin with an antiseptic.

The preparation is injected precisely into the joint cavity using standard techniques, taking into account the anatomical features of the patient. Administration into the joint cavity should be stopped if pain increases during the injection.

In case of intra-articular edema, it is necessary to remove the fluid by aspiration before administering hyaluronic acid.

Unused product must not be stored.

Side effects

The use of intra-articular forms of hyaluronic acid for degenerative-dystrophic and post-traumatic joint lesions is a well-studied method with an established safety profile, used for several decades.

In extremely rare cases, local temporary inflammatory symptoms may occur (pain, fever, redness and swelling, increased exudate content in the joint cavity). After intra-articular injection, such reversible local reactions as short-term limitation of mobility (stiffness), a feeling of discomfort or heaviness in the joint, and hematomas may occur. The manifestation of these symptoms can be reduced by applying ice to the injection site for 5-10 minutes.

There are reports of isolated cases of allergic reactions (e.g., itching, rash, urticaria) and anaphylactic reactions, septic arthritis, intratissue bleeding or hemorrhage into the joint cavity, tendinitis, phlebitis, paresthesia, dizziness, headaches, muscle cramps, feeling of heat, general malaise, peripheral edema with intra-articular administration of hyaluronic acid solutions.

If local or general symptoms appear, the patient should consult a doctor.

Contraindications

• Hypersensitivity to any of the components of the product;
• Septic arthritis;
• Skin infections or dermatological diseases in the injection area;
• Concomitant use of anticoagulants such as phenprocoumon or warfarin.

Use during pregnancy and lactation

Due to the lack of clinical data on the use of hyaluronic acid in the treatment of pregnant or breastfeeding women, the use of the product in these patient groups should be avoided.

Special instructions

During the first 2 days after the procedure, it is recommended not to overload the joint, especially avoiding prolonged stress.

If aspiration fluid is obtained before viscosupplementation therapy, appropriate tests should be performed to exclude the bacterial etiology of arthritis.

Because septic arthritis is a serious side effect, all standard precautions for surgical interventions must be observed.

The product is intended for intra-articular administration. Intravascular or intratissue administration of the product must be avoided.

In the first days after the injection, oral administration of analgesics or anti-inflammatory drugs may be useful.

The use of the product together with quaternary ammonium compounds is prohibited.

Re-sterilization and reuse of the product are prohibited due to the risk of infection, cross-infection, and/or product defect.

Flexotron^® Smart is intended for single use only.

Do not use a syringe from an opened and/or damaged sterile package. Do not use a syringe with an opened or damaged sterile syringe cap.

If the sterility is compromised or suspected to be compromised, the product must be disposed of.

Electromagnetic fields and ionizing radiation

Viscoelastic implants are compatible for use in magnetic resonance imaging conditions with a magnetic field induction of at least up to 3 Tesla. Radiation, electromagnetic, and magnetic fields do not have a direct effect on the Flexotron^® Smart implant and its properties, nor do they cause any known corresponding subsequent effects in the human body.

Viscoelastic implants cannot be visualized by radiological, ultrasound, and other scanning procedures due to the proximity of their physical properties to the natural components of human tissues.

Implant removal

In case of pronounced manifestations, removal of the implant from the joint cavity may be recommended, including with the use of lavage, according to current clinical guidelines.

If the reaction to the implant was not associated with individual intolerance to the product components, re-administration of the implant is possible 3 weeks after the inflammatory phenomena subside.

Use in pediatrics

Due to the lack of clinical data on the use of hyaluronic acid in the treatment of children, the use of the product in this patient group should be avoided.

Environmental protection and disposal

The contents of the syringe are not toxic or flammable.

Unused syringes can be disposed of as household waste. Glass should be disposed of with caution.

Unused contents of the syringe before or after the expiration date can be disposed of as household waste (flush with plenty of water).

Used syringes and needles are classified as epidemiologically hazardous waste (infected and potentially infected waste: materials and instruments, items contaminated with blood and/or other biological fluids). Disposal of these products is carried out in accordance with local and state regulations for the disposal of medical waste.

In accordance with SanPiN 2.1.7.2790-10, waste from this medical product after use belongs to class B: epidemiologically hazardous waste.

Effect on the ability to drive vehicles and mechanisms

The product does not affect a person’s ability to drive vehicles, engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

The Flexotron^® line of implants has successfully passed preclinical tests and confirmed compatibility with biological tissues, cells, and body fluids with which they come into contact in the implanted state.

Disinfectants containing quaternary ammonium salts should not be used, as hyaluronic acid precipitates in the presence of these substances.

There is currently no information on incompatibility with other medicines, substances, and intra-articular injectable products; however, the healthcare professional should carefully read the information in the instructions for these medicines/substances/products and use with caution.

Dispensing Status

Available without a prescription.

Storage Conditions

The product should be stored in the original packaging in a place inaccessible to children at a temperature from 2°C (35.6°F) to 25°C (77°F) and relative humidity of 30-60%; protect from light, do not freeze, avoid impacts and sharp shaking.

Shelf Life

Shelf life – 3.5 years. Do not use after the expiration date indicated on the packaging.

This medical product is transported by all modes of transport in covered vehicles in accordance with the requirements, rules, and regulatory documents for the transportation of goods in force for each mode of transport.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.