HyaRegen® 10 ml – hyaluronic acid-based absorbable adhesion barrier gel

HyaRegen® 10 ml – hyaluronic acid-based absorbable adhesion barrier gel

210.54 EUR

HyaRegen® 10 ml – absorbable barrier gel intended for the prevention or reduction post-surgical adhesion formation in the abdomino-pelvic area after laparoscopic, caesarean section and open gynaecological surgical procedures.

 

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Abdomino-pelvic surgical procedures are a frequent cause of adhesion formation, which may induce pelvic pain and/or infertility etc. These post-surgical adhesions are due to the formation of areas of contact, made of fibrous tissue, between adjacent internal organs. In order to prevent the formation of post-surgical adhesions it is recommended to use a product able to form a barrier against the contact between adjacent tissues, and to remain on the site of application for a period of time sufficient to avoid the formation of adhesions.

Absorbable Adhesion Barrier Gel is a sterile, transparent and highly viscous gel. The active component is cross-linked molecules of hyaluronan (HA) from non-animal source and the HA is made from fermentation in Streptococcus spec. HA is one of the main components of human connective tissue and of epithelial and mesothelial tissues. The cross-linking process makes HA more viscous and persisting longer in vivo. Therefore, the product has increased viscosity and extended residence time, and could also keep the same tolerability and biocompatibility with the original polymer.

The composition of the Gel is shown in the following table.

Components Content (Per ml)
Cross-linked Hyaluronan（HA） 5 mg
Sodium chloride（NaCl） 9 mg
Disodium hydrogen phosphate and Sodium dihydrogen phosphate （Na2HPO4，NaH2PO4） 0,694 mg
Water（H2O） QS to 1ml

The Gel is intended to be absorbed for not more than 30 days. One – two weeks after the application, it is almost completely reabsorbed, no matter what tissue or area was applied. Thanks to its viscosity, the Gel adheres to the tissue surface and creates an anti-adhesion barrier which keeps the adjacent tissues separated during the repair phase subsequent to a surgical procedure.

Absorbable Adhesion Barrier Gel may be benefit to prevent or reduce postoperative adhesions.

Intended Use

Absorbable Adhesion Barrier Gel is indicated for the prevention or reduction post-surgical adhesion formation in the abdomino-pelvic area after laparoscopic/hysteroscopic and open gynaecological surgical procedures.

Instructions for Use

  • Please visual inspection of the sterile barrier prior to use.
  • Open the protective package (Tyvek pouch or blister tray) and introduce the syringe to the operating field, adopting the normal aseptic techniques used in the surgical theatre.
  • Please be careful when opening the package to avoid contaminating the Injection Cannula and Gel with any non-sterile substances (eg. dropping on the floor while unpacking）. If the Injection Cannula and/or Gel have been contaminated, please do not continue to use.
  • Remove the protective cap on the tip of the syringe, and connect the syringe to an Injection cannula provided with product.

Figure 1 Schematic of product connection

  • Apply the gel inside the abdomino-pelvic cavity or uterine cavity by pushing the plunger.
    Cover all areas to be treated with enough gel. It is recommended to apply 3ml/10cm2 of gel.
    Do not irrigate the surgical field after application of the product.

Contraindications

Known hypersensitivity to hyaluronan or its derivatives.
The device must not be used in patients with infection or contamination of the surgical site.

Warnings and Precautions

  • Confirm that the surgical site is free of excessive bleeding. Excessive bleeding should be controlled prior to instillation.
  • The product does not have intrinsic bacteriostatic or bactericidal activity. It is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections. In the case of pre-existing infections, appropriate treatment should be instituted.
  • The concomitant use of the product with other anti-adhesion device has not been evaluated.
  • The product has not been evaluated with a dose of over 2ml/kg of body weight. It is not recommended using over a dose of 2ml/kg of body weight unless at the discretion of the physician.
  • The product has not been evaluated in patients affected by malignant tumors. Preclinical evidence has shown that the products have no influence on neoplastic diffusion.
  • Data on the use of this product on pregnant women and children are not available. The use of the products is not recommended in this condition. It is also recommended to avoid pregnancy during the first complete menstrual cycle subsequent to the treatment.
  • Do not inject intravascularly.
  • The product is intended only for surgical use by specialized surgeons in the patients underwent open and laparoscopic/hysteroscopic gynaecological surgical procedures in abdominopelvic area.
  • The product is provided as sterile and single use. Do not resterilize and or reuse.
  • It is recommended to use the product immediately after opening the pouch or the tray.
  • All the assembling operations of the device must be performed in the surgical theatre.
  • The product is single-use; any non-used product must be discarded accordingly. The reuse of the product may cause serious infection.
  • The empty containers have to be discarded accordingly.
  • Keep out of reach of children.
  • If the syringe and /or protective pouch or the blister is damaged, do not use the product and contact local distributor.
  • Do not use the product after the expiration date. When the Gel is expired, the Injection cannula will be invalid at the same time.
  • The product must be used according to the instruction for use. Read instructions prior to use.
  • The opened and non-used product should be disposed as medical waste according to local laws.
  • Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
  • Within 30 days of using the gel, if the patient undergoes an ultrasound, CT, or MRI scan, although these examinations do not affect the gel, the presence of the gel in the body may lead to misdiagnosis during the scans. Therefore, the patient should inform their doctor about the use of this device before undergoing such examinations.
  • Cross-linked sodium hyaluronate typically exhibits minimal or negligible effects in magnetic fields, external electrical fields, and electromagnetic environments. Therefore, this device generally does not have significant impacts related to magnetic fields, external electrical fields, and electromagnetic effects.
  • If it is encounter difficulty connecting the Injection Cannula and Syringe during use, please check if the syringe cap has been removed. If the cap has been removed and the connection is still unsuccessful, inspect the luer lock connection between the Injection Cannula and Syringe for any damage. Do not use if damage is detected.
  • If the Gel cannot be extruded after connection, check the Injection Cannula for any blockages. Do not use if a blockage is found.

Adverse Events

No device-related adverse effects were reported in the current clinical data. However, as with any surgically implanted biomaterials there might be the potential for adverse reactions, such as infection, foreign body reaction, and allergic reaction in rare circumstances.

Storage

Absorbable Adhesion Barrier Gel should be stored at 2°-30℃ and protection from sunlight. DO NOT FREEZE.

Shelf-life

The shelf-life of the Gel is thirty six (36) months from the date of manufacture, and Injection Cannula is sixty (60) months from the date of manufacture.

How Supplied

Absorbable Adhesion Barrier Gel consists of Gel and Injection cannula. The Gel is prefilled and sealed in syringe and then sterilized by steam. This syringe is served as the sterile barrier to keep the product sterile. Injection Cannula is packed in a Tyvek Pouch and sterilized by EO, provided in the same box.

Note:

The Summary of safety and clinical performance is available through the Eudamed. Here is the web site: https://webgate.ec.europa.eu/eudamed/landing-page. These information can also be obtained by sending an email to the manufacturer at info@bioregenmed.com.

Manufacturer

BioRegen Biomedical (Changzhou) Co., Ltd.
Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu, China
Tel: +86-519-88408555 Fax: +86-519-88407911
E-mail: info@bioregenmed.com
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537 Hamburg, Germany
Tel.: +49 40 2513175 Faks.: +49 40 255726

SKU: 6952181200196 Category:
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