Indications for Use:
The SaluBridge nerve cuff made from Salubria biomaterial is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Description:

SaluBridge is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap.

SaluBridge nerve cuff sutured in place

Product Offering:
Inner Diameters: 2, 5 and 10 mm
Length: 6.35 cm (material can be trimmed to size)
Each SaluBridge is supplied one to a package, sterile, and hydrated in saline for presentation onto the operative field.

References:
1. Lundborg, G., Rosen, B., Dahlin, L., Danielsen, N., Holmberg, J. (1997).
Tubular versus conventional repair of median and ulnar nerves in the human forearm: Early results from a prospective, randomized, clinical study. The Journal of Hand Surgery 22A: 99-106.

2. Mackinnon, S.E. (1989).
Surgical management of the peripheral nerve gap.
Clinics in Plastic Surgery 16(3): 587-603.

3. Mackinnon, S. E. and Dellon, A. L. (1994).
Chapter 4: Nerve repair and nerve grafting. In: Surgery of the Peripheral Nerve. Thieme, New York, pp. 89-129.


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Q: Can the SaluBridge nerve cuff be used to repair spinal cord injuries?
A: SaluBridge is not indicated for this use. SaluBridge is intended for the repair of peripheral nerves, not the central nervous system.

Q: What is SaluBridge made from?
A: The SaluBridge nerve cuff is constructed of Salubria biomaterial, a hydrogel that contains water in similar proportions to human tissue.

Q: Is SaluBridge biodegradable or absorbable in the body?
A: No, SaluBridge is biodurable, designed for permanent implantation.

Q: What techniques are currently used to repair peripheral nerve injuries?
A: Currently several techniques are available including use of a vein, muscle, vascular nerve autograft (from the patient), allograft (from a cadaver), or entubulation with an artificial graft such as SaluBridge.

Q: What size gap can be repaired with SaluBridge?
A: Although literature indicates that artificial nerve conduits have been used to repair gaps of up to 6 centimeters, most do not recommend entubulation repair for gaps greater than 5 centimeters or in areas of compound injuries.

Q: What advantages does the SaluBridge device offer over the autograft technique?
A: Autografting requires 2 operative sites and the permanent sacrifice of functional nerve. Neuroma and scar tissue formation may occur. Use of SaluBridge may reduce cellular invasion & scarring that may impede regeneration. It can be implanted in one procedure, resulting in shorter treatment times and does not sacrifice a donor site.

Q: How does SaluBridge compare to other artificial grafts?
A: SaluBridge is a synthetic device (not animal-based) made mostly of water and an organic polymer, similar to the hydrogels used in contact lenses. The device is biodurable as opposed to biodegradable. It is intended to be flexible and compliant, yet strong enough to hold its shape without collapsing.

Q: Where is SaluBridge available to patients?
A: SaluBridge has received clearance for sale in the United States, Europe, and Canada; however, the product is not commercially available while SaluMedica seeks an appropriate distribution network.

Q: How can I learn more about SaluBridge?
A: Please contact us toll free in the US at 1-866-SALUBRIA (1-866-724-8274) or internationally at +1-404-589-1727.


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pns.ucsd.edu/
www.microsurgeon.org/nerve_injury.htm
www.theuniversityhospital.com/peripheral/
www.assh.org
www.handsurgery.org
www.aans.org


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The SaluBridge nerve cuff for peripheral nerve repair received FDA clearance for the US market in late 2000, followed by the CE Mark in 2001 for sale in Europe, and the Medical Device License for sale in Canada in early 2002.

To purchase product in the United States contact SaluMedica. For orders outside of the US, click here for SaluMedica's international distributor list.

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