Remplir^TM

DESCRIPTION

Remplir^TM is a sterile, implantable, biocompatible, resorbable, collagen membrane intended for use in the management of peripheral nerve injuries. Remplir^TM is a single-ply sheet of porcine-derived, non-crosslinked collagen. Remplir is supplied as a single device in a double PETG/Tyvek blister pack in a labelled cardboard box. Remplir is available in 4 size variants for the convenience of clinicians (15mm x 20mm, 20mm x 30mm, 30mm x 40mm, 40mm x 50mm). All size variants are identical in composition and function.

INDICATIONS FOR USE

Remplir^TM is indicated for the management of peripheral nerve injuries.

PROPERTIES

Remplir^TM is designed to protect the injured nerve following repair and provide a favorable environment for nerve regeneration to occur.

Remplir^TM is soft and pliable with a smooth outer surface and rough inner surface, providing excellent handling characteristics.
Remplir^TM is wettable and may be sutured in place, if required.
Remplir^TM can be cut to the desired size and wrapped around the injured nerve in either its wet or dry form.

DIRECTIONS FOR USE

1. Follow standard procedures for nerve exposure and mobilization. Perform neurolysis and/or tensionless coaptation of nerve ends if required. If present, the gap between nerve ends should not exceed 20mm.
2. Trim Remplir^TM to desired size, if required.
3. Hydrate if desired with sterile saline or other physiological solution. Device is full hydrated when uniformly translucent.
4. Wrap Remplir^TM around the site of the nerve repair, with the rough surface of the device facing the nerve.
5. Fix Remplir^TM in place with sutures, if required. Do not compress the nerve.
6. Follow standard post-operative procedures and care. Application of Remplir^TM does not modify post-operative treatment.

CONTRAINDICATIONS

The use of Remplir^TM in patients with known sensitivity to porcine-derived materials or collagen is contraindicated.

ADVERSE REACTIONS

Possible complications of peripheral nerve surgery include pain, infection, swelling, inflammation, foreign body sensation and changes in nerve sensitivity (paresthesia or hyperesthesia) at the implant site.

Adverse reactions to porcine- derived collagen nerve wraps such as Remplir^TM are extremely rare.
Patients should be monitored closely in the initial post-operative period to identify and address any adverse reactions that may occur.

PRECAUTIONS

Peripheral nerve repair with Remplir^TM should only be undertaken by suitably qualifieded surgeons.
Remplir^TM should be used with caution in infected regions.
Do not use if the product package is damaged or opened.

STORAGE AND HANDLING

Store Remplir^TM in its original packaging at room temperature (15-25°C /59-77°F) in a dry place.

HOW SUPPLIED

Remplir^TM is supplied in a double PETG/Tyvek blister pack contained in a labelled cardboard box.

MANUFACTURER

Orthocell Ltd
Building 191, Murdoch University
South Street, Murdoch WA 6150 Australia

SYMBOLS USED IN LABELLING

Use-by date

Batch code

Catalogue number

Date of manufacture

Sterile using irradiation

Double sterile barrier system

Do not resterilize

Do not re-use

Do not use if package is damaged and consult Instructions for use

Contains biological material of animal origin

Keep dry

Keep away from sunlight

Temperature limit

Consult instructions for use

Medical Device

Unique Device Identifier

MR Safe

Prescription only

Device size

Manufacturer