Xenograft dural substitute DURASHEET™

collagen

Product Overview
DURASHEET™ is a single-use, collagen-based implant composed of ultra-pure, medical-grade type-1 bovine collagen (purity > 95.5%) designed as a biological substitute for the dura mater in cranial and spinal neurosurgical applications. The membrane provides a natural, biocompatible scaffold to support tissue integration, sealing, and healing while minimizing foreign body response.

Key Material Properties
DURASHEET™ is engineered from type-1 bovine collagen with an impermeable pore structure that delivers exceptional fluid barrier properties and reduces the risk of cerebrospinal fluid (CSF) leakage. The membrane gradually biodegrades and is replaced by native connective tissue, avoiding long-term complications associated with some synthetic substitutes.

Engineered for Clinical Excellence
DURASHEET™ is ready to use out of the package and can be quickly cut to size, shaped, and positioned according to anatomical and surgical needs. It is suitable for both elective and emergency procedures where time efficiency and reliability are critical.

Key Clinical Benefits

• More suturable: engineered to withstand suturing for secure mechanical fixation to surrounding dura or fascia.
• Superior tensile strength: reinforced to resist tearing or rupture during manipulation and placement.
• Dual-surface usability: both sides of the membrane are usable, reducing orientation errors and simplifying application.
• High absorption capacity: porous microstructure allows effective absorption of fluids, aiding adhesion and healing.

Versatile Applications Across Neurosurgery
DURASHEET™ is suitable for a variety of dural and spinal defects, including but not limited to:

• Craniotomies with dural resection
• Spinal tumor resections
• Trauma-related dural breaches
• Myelomeningocele and lipoma repair
• Chiari malformation decompression
• CSF fistula closures
• Congenital spine defects

The membrane adapts well to natural contours and can be used as a primary dural substitute or as an overlay patch to reinforce existing closures.

Radiation Sterilized and Biologically Safe
DURASHEET™ is sterilized by gamma irradiation, ensuring deep penetration and microbial elimination. The product is free from endotoxins and pyrogens and is packaged in double-sterile pouches. Each unit is single-use and available in multiple sizes for different defect geometries.

Available Sizes for Tailored Solutions
Reference Code — Product Description
DRS2525 — DURASHEET™ Collagen Dura Membrane 2.5 x 2.5 cm
DRS5050 — DURASHEET™ Collagen Dura Membrane 5 x 5 cm
DRS7575 — DURASHEET™ Collagen Dura Membrane 7.5 x 7.5 cm
DRS100100 — DURASHEET™ Collagen Dura Membrane 10 x 10 cm
These size variations enable surgeons to select the most appropriate sheet for the anatomical region and extent of the defect, minimizing waste and intraoperative trimming.

Ideal Handling Characteristics
DURASHEET™ maintains structural integrity when wet, remains flexible, resists curling or fragmentation, and can be anchored with standard neurosurgical sutures or used as an onlay with biological adhesives. Its white, non-transparent appearance allows excellent visibility under the operating microscope, and the sheet supports stable manipulation with standard forceps.

Biocompatibility and Performance Confirmed
The membrane has undergone biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implant response) meeting ISO 10993 standards. It has also been evaluated under CSF pressure simulations confirming sealing performance and durability.

Supporting Rapid Healing
Thanks to its collagen-rich matrix and absorption profile, DURASHEET™ promotes angiogenesis and fibroblast infiltration and facilitates reformation of a natural dural layer as the material is gradually resorbed and replaced by native tissue.

Technical specifications

• Composition: Type-1 bovine collagen, medical-grade, purity > 95.5%
• Use: Single-use implant, biological dural substitute
• Sterilization: Gamma irradiation
• Endotoxins / Pyrogens: Product supplied free from endotoxins and pyrogens
• Packaging: Double-sterile pouches, individually packaged
• Handling: Ready-to-use, cut-to-size, dual-surface usable, suturable, maintains integrity when wet
• Mechanical: High tensile strength, resistant to tearing
• Barrier function: Impermeable pore structure with exceptional fluid barrier properties
• Biologic performance: Gradual biodegradation/resorption; supports angiogenesis and fibroblast infiltration
• Standards & Testing: Biocompatibility testing per ISO 10993; CSF pressure simulation testing performed
• Available references/sizes: DRS2525 (2.5 x 2.5 cm), DRS5050 (5 x 5 cm), DRS7575 (7.5 x 7.5 cm), DRS100100 (10 x 10 cm)
• Appearance: White, non-transparent