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Products

TissuePatchDural™ Sealant Film

The next generation of cerebrospinal fluid leak prevention

TissuePatchDural™ Product 1
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Overview

Seal with confidence

TissuePatchDural™ is a self-adhesive film indicated for use to seal and reinforce against fluid (including CSF) and/or blood leakage, where repair of the dura mater is required.1

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Features and Benefits

SELECT with confidence

  • Co-developed with surgeons to meet clinical requirements
  • Provides more uniform coverage across application sites as compared to DuraSeal®**
  • Ready to use requiring no preparation

**Shown in pre-clinical models.

PLACE with confidence

TissuePatchDural™ is only 0.04 mm thick and transparent1

  • Designed for use in confined spaces
  • May swell slightly to a total thickness of <0.5 mm
  • Resulting in minimally added compression
  • Offering an unrestricted view of the dura closure
  • Clear film with visible TissuePatch logo in Methylene Blue to aid in correct product orientation
  • Enabling identification that the dural seal is watertight
Versatile Applicator

SEAL with confidence

TissuePatchDural™ is a self-adhesive patch

  • Comprised of TissueBond™, a patented polymer technology, shown during bench testing to provide superior target tissue adhesion*
  • Designed to create a (chemical) covalent bond and help the product securely adhere to the target tissue
  • Exhibits superior adhesion in vitro compared to other dural sealants*2,3

*Compared to DuraSeal™ and Tachosil™ Fibrin Sealant Patch.

Related Videos

TissuePatchDural™ Sealant Film Application

TissuePatchDural™ following redo craniotomy video

TissuePatchDural™ In vitro Handling video

TissuePatchDural™ used for closure of midline spinal durotomy video

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References

Please note, not all products, services or features of products and services may be available in your local area. Please check with your local BD representative.

References
  1. TissuePatchDural™ Instructions for Use. See full Instructions for Use for detailed application instructions.
  2. Campbell P, Bennett S, Driscoll A, Sawhney A. Evaluation of Absorbable Surgical Sealants : In vitro Testing. Medicine. 2005.
  3. Ambridge A. Adhesive Sealant Biomaterials Technical Bulletin. In vitro performance of TissuePatchDural™ compared with DuraSeal® . 2009.

Indications for use: TissuePatchDural™ is indicated for use to seal and reinforce against fluid (including CSF) and/or blood leakage where the repair of the dura mater is required. TissuePatchDural™ is intended for use as an adjunct.

Contra-indications for use: TissuePatchDural™ is not intended for intravascular use; not intended to be used as a dura mater substitute; not intended to replace sutures, staples or clips, as appropriate, in tissue approximation.

Warnings and safety information:

  • TissuePatchDural™ should not be used on patients with a known allergy or sensitization to its constituent components. The use of must be considered on an individual basis.
  • TissuePatchDural™ should not be used as the primary means of support. The product is to be used as an adjunct, providing temporary support.
  • TissuePatchDural™ is not a thrombogenic haemostat. It should not be used to control arterial bleeds; it can however be used adjunctively to control low pressure oozing/bleeding.
  • TissuePatchDural™ should not be used on the skin.
  • If there is any evidence of damage to TissuePatchDural™ the product shall NOT be used.
  • TissuePatchDural™ should not be used if an active infection is present at the surgical site.
  • TissuePatchDural™ adhesion can be affected by contact with solutions containing iodine. Such substances should NOT be applied to the site before sealing with TissuePatchDural™, though can be used following patch application.
  • TissuePatchDural™ may swell slightly to a total thickness of <0.5mm. Care should therefore be taken when using the product in confined bony structures where nerves are present.
  • TissuePatchDural™ may cause a local, mild inflammatory reaction leading to encapsulation by inflammatory cells with some fibrosis.
  • TissuePatchDural™ is for single patient use only and once opened may not be resterilised. Product should not be re-used as this presents numerous hazards including the risk of cross contamination and lack of sterility.
  • DO NOT use TissuePatchDural™ if temperature indicator dot is black; this indicates that the product has been exposed to excessive temperatures and is not suitable for use.

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions.

BD-83468

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