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Integra LifeSciences

DuraSeal® — Dural sealing system

An absorbable synthetic dural sealant — a polyethylene glycol (PEG)-based hydrogel applied as an adjunct to dural suturing, which within seconds forms a watertight, visible (blue) closure to prevent cerebrospinal fluid leaks in cranial and spinal surgery.

Neurosurgery
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DuraSeal® — application of the blue dural sealant with the dual-tip applicator (Integra material)
100%Intraoperative success
>90%Water content
a few secondsSealing
4–8 weeksResorption
Clinical description

DuraSeal® is a dural sealing system developed to reinforce the repair of the dura mater and support the natural healing process, providing a watertight closure intraoperatively and throughout the critical period of dural healing. It is used as an adjunct to standard repair methods — particularly suturing — and not as a substitute for them.

The system consists of two precursors that, when combined at the applicator tip, cross-link rapidly: the blue precursor contains a polyethylene glycol (PEG) ester and an FD&C Blue #1 colorant, while the colorless precursor contains trilysine amine in a buffer solution. The cross-linking reaction occurs at the application site in approximately three seconds, with no heat generation, forming a flexible, biocompatible hydrogel that contains more than 90% water. The distinct blue colorant allows the surgeon to visually assess the coverage and thickness of the sealant (recommended layer of approximately 1–2 mm).

The hydrogel is fully synthetic, free of human- or animal-derived products, latex-free, and MRI-compatible. It resorbs through hydrolysis and renal elimination — in approximately 4–8 weeks for the cranial variant, sufficient to allow normal wound healing. The system is prepared in less than two minutes, stored at room temperature (≤25°C), and must be used within one hour of preparing the blue precursor. The range includes the cranial DuraSeal® variant and the spinal DuraSeal® Exact / Xact variants, alongside dedicated applicators (8 and 15 cm extended tip, gas-assisted MicroMyst® applicator with flow regulator).

Indications
  • Adjunct to standard dural repair methods (sutures) to achieve a watertight closure, in cranial and spinal surgery.
  • Prevention of cerebrospinal fluid (CSF) leaks after duraplasty.
  • Decompressive duraplasty in Chiari malformation (clinically evaluated).
  • DuraSeal® Exact / Xact: adjunct to dural suturing in spinal surgery.
Key features

Synthetic PEG hydrogel

Absorbable sealant based on polyethylene glycol + trilysine amine — biocompatible, fully synthetic, of non-animal origin.

Watertight closure in seconds

Rapid cross-linking (~3 sec) at the application site, with no heat generation; immediate watertight seal.

Visible (blue colorant)

The distinct colorant allows visual assessment of the coverage and thickness of the applied layer.

Absorbable

Complete resorption through hydrolysis and renal elimination in ~4–8 weeks (cranial variant).

Cranial and spinal

Range for both indications — DuraSeal® (cranial) and DuraSeal® Exact / Xact (spinal).

Dedicated applicators

Dual-tip applicator included; extended-tip applicators (8 / 15 cm) and MicroMyst® for deep and minimally invasive areas.

Practical in the operating room

A single kit, preparation in <2 min, storage at room temperature (≤25°C).

Technical specifications
Type
Absorbable synthetic dural sealant (PEG hydrogel), adjunct to dural suturing
Composition
Blue precursor — polyethylene glycol (PEG) ester + FD&C Blue #1 colorant; colorless precursor — trilysine amine in buffer solution; hydrogel with more than 90% water
Mechanism
Cross-linking of the two precursors at the applicator tip → flexible, watertight hydrogel, with no heat generation (polymerization ~3 sec)
Visualization
Distinct blue colorant for assessing coverage and thickness (~1–2 mm layer)
Resorption
Cranial variant ~4–8 weeks; DuraSeal® Xact spinal ~9–12 weeks (hydrolysis + renal elimination)
Preparation / use
Preparation <2 min; use within 1 hour of preparing the blue precursor; storage at ≤25°C
Variants
DuraSeal® (cranial, 3 / 5 ml) · DuraSeal® Exact / Xact (spinal, 3 / 5 ml)
Applicators
Dual tip included; extended tip 8 / 15 cm; gas-assisted MicroMyst® applicator + FR-6065 flow regulator (optional)
Device class
III (Annex IX, Rule 8, MDD 93/42/EEC); notified body TÜV 0123
Sterilization / safety
Irradiation (e-beam); single-use; fully synthetic, of non-animal origin; latex-free; MRI-compatible
Shelf life
18 months (unopened)
Warning
Do not apply in closed bony structures where nerves/spinal cord are present (risk of compression from hydrogel swelling); do not use as an abdominopelvic anti-adhesion barrier
Clinical evidence

A selection of publications and studies that mention use of the system. Summaries are indicative; for details, consult the original source.

Safety and Efficacy of a Novel Polyethylene Glycol Hydrogel Sealant for Watertight Dural Repair

Cosgrove G.R., Delashaw J.B., Grotenhuis J.A. și colab. · Journal of Neurosurgery, 2007; 106(1):52–58

Prospective clinical investigation of the DuraSeal® dural sealant applied as an adjunct to duraplasty, in patients undergoing craniotomy/craniectomy (including decompressive duraplasties for Chiari malformation). The maintenance of a watertight closure, with no apparent CSF leakage on the Valsalva maneuver, was assessed.

In the 111 patients treated, the intraoperative success rate was 100% in maintaining a watertight closure, with no apparent CSF leakage; no leaks were recorded at the 3-month reassessment.

Use of a Novel Absorbable Hydrogel for Augmentation of Dural Repair: Results of a Preliminary Clinical Study

Boogaarts J.D., Grotenhuis J.A., Bartels R.H.M.A., Beems T. · Neurosurgery, 2005; 57(1 Suppl):146–151

Preliminary, prospective clinical study on the augmentation of dural repair with the sealant hydrogel, monitoring the occurrence of CSF leaks in the early postoperative period.

In 47 patients, the success rate of watertight closure was 95.3% at the one-month reassessment.
Certifications & compliance
CE marking (MDD 93/42/EEC) Class III — notified body TÜV 0123 ISO 13485 MRI-compatible Latex-free, of non-animal origin

Product code: DSD5001 (3 ml) · DS-D-5005 (5 ml) · DuraSeal® Exact 206320 / 206520 · DuraSeal® Xact 203001 / 204003

Device class: III (MDD 93/42/CEE)

Images
DuraSeal® — the hydrogel formation mechanism: combining the blue precursor (PEG) with the colorless one (trilysine amine), cross-linking in ~3 sec, gel with >90% water and resorption in ~4–8 weeks (Integra material)
DuraSeal® — the hydrogel formation mechanism: combining the blue precursor (PEG) with the colorless one (trilysine amine), cross-linking in ~3 sec, gel with >90% water and resorption in ~4–8 weeks (Integra material)
DuraSeal® — intraoperative sequence of sealant application in decompressive duraplasty for Chiari malformation (Integra material)
DuraSeal® — intraoperative sequence of sealant application in decompressive duraplasty for Chiari malformation (Integra material)
DuraSeal® Exact — dural sealant for spinal surgery (watertight dural repair at the spine)
DuraSeal® Exact — dural sealant for spinal surgery (watertight dural repair at the spine)
Resources
Integra LifeSciences — DuraSeal