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Nerve Wrap is indicated for the management of peripheral nerve injuries where there is no gap.

The proposed BioCircuit Technologies, Inc. Nerve Wrap device is composed of a bioabsorbable, layered extracellular collagen matrix (decellularized porcine small intestinal submucosa, SIS). The SIS material that comprises the Nerve Wrap is identical to the backing material of its reference predicate, Nerve Tape (K233533). The Nerve Wrap is implanted around a damaged peripheral nerve to provide a scaffold which becomes infiltrated and remodeled by the patient's cells. The device protects the nerve while the nerve heals and provides a non-constricting interface between the nerve and the surrounding tissue. The device is packaged and supplied sterile in a clamshell container inside a sealed pouch. The dimensions of the finished device are 45mm x 22mm, with 2 - 3 layers of laminated SIS. The device is intended for implantation around nerves of diameters up to 7mm.

Remplir is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Remplir™ is a sterile, implantable, biocompatible, resorbable, collagen membrane intended for use in the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Remplir™ is a single-ply sheet of porcine-derived, non-crosslinked collagen. It presents as a soft and pliable, white to off-white membrane with distinct smooth and rough surfaces. The primary aim of surgical repair is to re-establish nerve continuity so that regenerating axons are guided into the distal nerve stump with minimal loss of nerve fibres at the repair site. Remplir™ is designed to protect the injured nerve. The device can be cut to the desired size and wrapped around the injured nerve in either its wet or dry form. It is wrapped around the site of nerve repair, intended to provide a favourable environment for nerve regeneration and prevent ingrowth of connective tissue. 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 (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm, 40 mm x 50 mm.). All size variants are identical in composition and function.

Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets. The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons. When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.

NerveTape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.

The proposed BioCircuit Technologies, Inc. NerveTape device is composed of a bioabsorbable, extracellular collagen matrix (small intestinal submucosa, SIS) with integrated microhooks made of a nickel-titanium alloy, commonly referred to as NiTiNOL (identical to the predicate), for mechanical fixation and apposition of nerve ends. The NerveTape is implanted around an injured nerve to provide a scaffold which becomes infiltrated and remodeled by the patient's cells. The device protects the damaged or severed nerve while the nerve heals. The device is packaged and supplied sterile in a clamshell container inside a sealed pouch. The device is identical to the predicate, except for the SIS substrate manufacturer and the addition of a smaller size. The dimensions of the finished device range from 11mm x 12mm x 22mm. The device is intended for the repair of nerves of diameters ranging from 1.5mm to 7mm.

Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

The Rebuilder Nerve Guidance Conduit is designed to be a permeable and bioresorbable poly(lactide-co-caprolactone) based tube. It is designed to serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury. The Rebuilder Nerve Guidance Conduit offers guidance and protection for axonal growth across a nerve gap. The Rebuilder Nerve Guidance Conduit is provided sterile, non-pyrogenic, for single use only, in various sizes (with product inner diameter ranging from 1.5mm to 10 mm). The Rebuilder Nerve Guidance Conduit is provided in double peel package.

VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant. VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve.

Axoguard HA+ Nerve Protector is indicated for the management and peripheral nerve injuries where there is no gap, or following closure of the gap.

Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also providing tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon's needs.

Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where is no gap.

The Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerves. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet surgeons' needs.

Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.

The Nerve Tape device is composed of a bioabsorbable, extracellular collagen matrix derived from small intestinal submucosa (SIS). Microhooks made of a nickel-titanium alloy (NiTiNOL) are integrated into the nerve contacting side of the SIS for mechanical fixation and apposition of nerve ends. The device is packaged in a dried state and supplied sterile, and is rehydrated prior to use.

The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity.

The NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, whitish to light beige colored, freeze-dried, pre-cut, flat sheet of acellular collagen. The NervAlign® Nerve Cuff is available in three (3) different sizes: 10x10mm, 20x30mm and 30x40mm. The collagen material that comprises the Nerve Cuff is derived from the same species as that of the predicate nerve cuff (AxoGuard Nerve Protector; K132660) manufactured by Cook Biotech Incorporated. Like the predicate, the NervAlign® Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodelled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The NervAlign® Nerve Cuff is packaged in a dried state, is for single use and provided sterile.