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The SaluBridge nerve cuff is intended to provide a protective environment for peripheral nerve repair after injury. Nerves have been demonstrated to successfully regenerate across a gap when an entubulation technique is utilized. The SaluBridge nerve cuff eliminates the need for a nerve graft, thereby removing the risk of donor site morbidity. SaluMedica is pursuing a distribution network to make SaluBridge commerically available to the market at this time.

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PATIENTS INFORMATION:

Injuries to the nerves may heal if a suitable guide for nerve regeneration can be implanted. The SaluBridge is a tube designed to help restore function to patients with peripheral nerve injuries by acting as a bridge through which nerve endings may regenerate.


DEFINITIONS:

The Peripheral Nervous System
The peripheral nervous system (PNS) is one of the two major divisions of the nervous system. The other is the central nervous system (CNS), which consists of the brain and spinal cord. The PNS consists of peripheral nerves and their receptors, nerve roots adjacent to the spinal cord, and sensory, sympathetic and enteric neurons.

Peripheral Nerve Injury
Nerves contain many fibers (axons), which may be sensory (providing feeling in a defined area) or motor (activating muscles and sweat glands). Nerves are fragile and can be injured by pressure, stretching or cutting. Peripheral nerves, which relay messages between the brain and the body, can sustain damage due to injury, disease, or medical disorder. Pressure or stretching can cause the fibers carrying information to break without damaging the cover or insulation but when a nerve is severed, both the nerve and the insulation are cut. If not repaired, the growing nerve fibers may grow into a ball at the end of the cut, forming a nerve scar or neuroma, which can be painful and cause an electrical feeling when touched.

Repair and Recovery
When a nerve is repaired the fibers sprout out of the nerve ending and grow across the gap towards the other end of the nerve. The result of nerve repair is unpredictable, but it is noted in the literature that the best recovery that can be achieved is 90%. Recovery can fail for many reasons, such as infection or scarring. Motor nerves are more resilient and may be more likely to heal than sensory nerves. The time required for regeneration is noted to be a function of the nerve location, age of the patient, and the gap length.


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FREQUENTLY ASKED QUESTIONS:

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. Click here for more information.

Q: How can I inform my doctor about SaluBridge?
A: Please encourage your physician to visit our web site or 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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HELPFUL LINKS:

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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