DURAMESH ENGLISH – PRO-BS – Materiais inovadores e de qualidade para suprir o setor de Saúde

DURAMESH LYO

A versatile and reliable duraplasty solution

Duramesh Lyo

Duramesh (previously marketed as AudioMesh Neuro and Lyomesh Neuro VR, respectively) are biological membranes derived from equine deantigenated pericardium, intended to be used as surgical collagen membranes during neuro surgical procedures for a CSF-impermeable sealing of Dura Mater defects.

• Biocompatible, native colagen and resorbable graft
• Equine BSE-Free source
• Can be sutured, glued for fixing or both
• Transparent membrane to allow visual control
• Shape memory for easy handling
• Suitable for both overlay and underlay technique
• 100% impermeable to CSF
• Available in liquid medium

Duramesh is conserved in a liquid, alcoholic-based solution. The reason why choosing equine source, lies in the immunity of the horse to Bovine Spongiform Encephalopathy (BSE)1. BSE, also called “mad cow disease” is a contagious infection caused by a prion, a pathogen impossible to sterilize without damaging the structure of the membrane.

Thanks to equine BSE free source, it’s possible to deantigenate and sterilize the membrane conserving native collagen fibers network, as shown in SEM imaging analysis. This particular process gives to the membrane Duramesh / Duramesh Lyo unique features, particularly useful for its surgery purpose. Biosynth processing technology, in fact, enables to keep native collagen fibers and make them compact, thus reducing pericardium thickness.

After the treatment, the layer becomes transparent, allowing to keep the visual check of the underneath tissues during the whole surgery. At the same time, the membrane remains extremely resistant: for this reason, Duramesh is suitable even for those surgeries with a high CSF pressure – such as in the posterior cranial fossa – where a very tight fixation is recommended.

Moreover, the membrane acquires a shape memory, so that it will easily lay flat providing an excellent adaptability to any anatomy. The collagen compacting procedure increases the sheet suturing resistance of the membrane as well. The sheet traction and pressure resistance indexes are higher than the ones of the collagen gel obtained through purification and artificial reticulation. The conservation in liquid gives to the membrane a high handling, thanks to its prehydrated state. The conservation liquid needs to be rinse as described in the Instruction For Use.

• Duramesh is water tight and prevents CSF leakages

• Thanks to its high mechanic resistance it can be easily fixed with fibrin glue and/or suturing points

• Differently from other devices currently on market which are thicker and harder, the transparency, biocompatibility and adaptability of Duramesh make this membrane an excellent dural substitute

• It doesn’t adhere on cerebral córtex, essential requirement for a fast and safe Dura Mater healing

• Duramesh is thin and transparent and – since it’s free from any additives – is highly tolerable

Duramesh is a membrane derived from equine pericardium and processed chemically to remove cells, pathogens and pyrogenic elements. Duramesh has to be used as Dura Mater replacement or reinforcement in neurologic surgeries to grant CFS impermeability. The dense network of collagen fibers provides a high resistance of the graft and grants to the cells an optimal tissue to regenerate Dura Mater.

• Class III medical device according to European classification 93/42/CEE and following edits
• Certified according to EN ISO 13485
• Beta rays sterilized
• Double sterile packaging for hygienic transfer to the sterile surgery area
• Hundred thousand units sold in more than 15 years (device previously known as Audiomesh Neuro)

Warnings
Duramesh is intended for use in cranial and spinal procedures where the reinforcement or substitution of the dura mater is needed. Duramesh is contraindicated in patients with known sensitivity to equine derived materials. Do not use in repair of neural tube defects or anterior spinal surgeries with dural resection. See instruction for use for additional information.

HOW TO START
STEP 1 – OPEN
• Before implantation, rinse Duramesh in saline or isotonic solution as written in the Instructions For Use.

STEP 2 – IMPLANTATION
• Duramesh can be easily cut and shaped with scissors

STEP 3 – FIXATION
• During on-lay procedure, the implant should overlap the dura defect by about 1 cm to ensure a proper adhesion and a safe CSF-tight barrier
• Duramesh can be sutured, glued (with fibrin glue) or both at surgeon’s
choice, depending by the fixation needed
• Other sealants can also be used to fix the membrane water-tightly

DOWNLOAD DURAMESH BROCHURE

INSTRUCTIONS FOR USE