Flexotron® CROSS

Synovial viscosupplement device for intra-articular injections Flexotron® Cross, based on cross-linked sodium hyaluronate 2%, 60 mg/3.0 ml, syringe No. 1.

1 injection per treatment course is sufficient.

  • Bionic cross-link is a combination of natural and real cross-link.
  • Created using the patented CHAP technology – an abbreviation for Cross-linked Hyaluronic Acid Platform.
  • CHAP allows the product to be administered easier and be better tolerated by patients.
  • 1 injection is sufficient
  • Produced in Taiwan by leading manufacturer of SciVision Biotech, Inc. from Japanese substance SHISEIDO


Recommendations for use
Name of the medical device
Sterile viscoelastic implant for intra-articular injections Flexotron® CROSS, based on cross-linked sodium hyaluronate, 60 mg/3.0 ml
Composition of the medical device
Sodium hyaluronate 2%
Phosphate buffer saline solution:
Sodium chloride 0.85%
Water for injection, as needed up to 100%
Specifications: pH 6.8-7.8
viscoelasticity (G '/ G ") 100-200 Pa /20-40 Pa.
osmolality value 0.9-1.3 to 0.9% saline
osmolality 270~390 mOsm/kg
Purpose of the medical device
The medical device is used to treat joint pain in osteoarthritis (OA).
Therapeutic efficacy:
The implant allows to balance the external mechanical loads on the joint.
The implant acts as a barrier protecting the joint.

Purposes:

Flexotron® CROSS implant
Cross viscoelastic sterile for intra-articular injection is a medical device based on cross-linked sodium hyaluronate, supplied in glass syringes. The device is a colorless, transparent, viscous, sterile, non-pyrogenic solution. Stabilized hyaluronic acid is obtained by extraction from microorganisms. The product is for single use only. Hyaluronic acid is a natural polysaccharide and an important structural element of the skin, subcutaneous and connective tissues, and in particular synovial fluid. Hyaluronic acid is highly biocompatible and is the same in all life forms. 1 ml of the implant contains 20 mg of sodium hyaluronate in phosphate buffered saline.

Indications:
The medical device is indicated for the treatment of joint pain in osteoarthritis (OA).

Contraindications:
• Do not use the implant to treat patients with hypersensitivity to hyaluronate-based products.

• Intra-articular injections are contraindicated in case of previous or current infections or skin diseases in the immediate vicinity of the injection site.

Warning: The medical device is intended for use as an intra-articular implant. The implant must not be re-sterilized or mixed with other medicinal products.

Avoid inserting the implant into blood vessels and surrounding tissues. The attending physician should be especially attentive to patients who have a history of allergic reactions to medicinal products, as well as liver disease.
Do not use the implant if its package is damaged. Repeated use of the same syringe with the implant can lead to infection and serious inflammatory reaction.

ElderlyDue to the weakened state of the body in the elderly, the attending physician must closely monitor their condition when the implant is used. Pregnancy and lactation

If the expected positive therapeutic effects outweigh the negative side effects, an implant is recommended. Breastfeeding should be interrupted during treatment for breastfeeding women.

ChildrenThere is no accurate data on the safety of the implant in children, so the doctor must carefully monitor pediatric patients during treatment.

Possible side effects:
The main side effects of the implant are pain, swelling, and stiffness in the knee where the injection was made.

Attention!

Do not twist or turn the syringe piston as this may cause the implant leakage, deform the piston and increase the extrusion force. The syringe, needle and any unused materials must be disposed of immediately after the injection. Do not use the implant if its package is damaged. Read the instructions carefully before use.


Method of administration:

The implant is injected in the volume contained in one syringe for one adult patient in the joint affected by osteoarthritis (OA).
The implant is injected directly into the joint.

The device is prescribed as a recommended treatment course of 1 syringe intra-articularly for adults in the joint affected by osteoarthritis (OA). The product is injected in the joint cavity. The dosage is 3 ml per treatment course, so all the contents of the syringe should be administered to adults. The efficacy of the device is maintained for at least 6 months.
Before the injection, you must:

1. Remove the covering membrane and remove the filled syringe with the implant from the blister.
2. Carefully remove the cover with the protective cap upwards.
3. Attach the sterile needle of the appropriate size (21-23G) and secure it by turning it slightly.
4. Before injection, release air bubbles from the syringe, if any.

Conditions of use:

The device is intended for use by qualified specialists and healthcare professionals in licensed institutions or hospitals.

Precautions for use.

General precautions for intra-articular injections and measures to prevent infection of the joint should be observed. The implant should only be injected into the joint cavity, using visual inspection if necessary. Avoid contact of the medical device with surrounding tissue or blood vessels! Exercise increased caution in case of inflammatory conditions in the joint. Not recommended for use in active rheumatoid arthritis.

Extraction of the implant.
In case of pronounced manifestations, removal of the implant from the joint cavity may be recommended, including the use of lavage according to current clinical guidelines. It is prohibited to re-inject synovial fluid implants into the joint until the symptoms of acute inflammation have resolved!
Description of operation principles
The product is indicated for the treatment of osteoarthritis (OA) joint pain in patients who fail to respond adequately to conservative non-drug therapy and mild analgesics.

The recommended course of treatment involves the intra-articular injection of the contents of 1 syringe to an adult patient in a joint affected by osteoarthritis (OA). The product is used for intra-articular injection. The therapeutic effect of the product remains for at least 6-12 months.

The hyaluronic acid molecule has a helical long chain structure that allows water molecules to be retained or absorbed. These properties provide a lubricating and cushioning effect within the joint. Osteoarthritis, known as degenerative arthritis, often results in collagen breakdown and loss of proteoglycans. Hyaluronic acid injection can protect the tissues of the joint cavity by alleviating external mechanical pressure.

Chemical properties: The implant is a colorless, transparent, viscous, sterile and pyrogen-free hydrogel. The functional ingredient of the product is 2% hyaluronic acid obtained by fermentation of Streptococcus zooepidemicus bacteria.

1,4-butanediol diglycidyl ether (BDDE) is used as a cross-linking agent to produce cross-linked hyaluronic acid.
Transportation
Permissible temperature limits from 2°С to 30°С. Keep away from sunlight and freezing.
Storage and shelf life
Store in accordance with the information indicated on the package at room temperature. Permissible temperature limits from 2°С to 30°С. Avoid exposure to sunlight, do not freeze.

Shelf life: 3 years.
Warranty liabilities
Implant Flexotron® CROSS is a single use product. The synovial fluid prosthesis has a limited shelf life of 3 years from the date of manufacture. The expiration date is indicated on the package ("Use before") and is valid under the conditions of transportation and storage.
Manufacturer
SciVision Biotech Inc., Taiwan
SciVision Biotech Inc.
9, South 6th Rd., K.E.P.Z., Kaohsiung 806, Taiwan, R.O.C.
E-mail: service@scivision.com.tw
Tel.: +886-7-823-2258

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