Search Results

The allay™ Nerve Cap is indicated for use in individuals weighing 25 kg or more as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.

The allay™ Nerve Cap is a sterile, absorbable, in situ forming, hydrogel barrier composed of water and polyethylene glycol (PEG) that reduces the risk of neuroma formation by providing a protective cover around the end of a nerve. The hydrogel forms in seconds after delivery of the precursor solutions around a nerve placed in a temporary silicone Cap Form. The Cap Form is then readily removed and discarded, leaving the nerve end wrapped in a transparent compliant gel that conforms to the nerve to prevent nerve outgrowth from the proximal stump for over 3 months, the critical period during which neuroma formation can occur. The hydrogel Nerve Cap is biocompatible, non-constrictive and non-neurotoxic and is absorbed from the site within 8 months with no evidence of systemic toxicity.

The device consists of various components for the preparation of the hydrogel, a dedicated applicator for the mixing and delivery of the two-component PEG/Accelerator Solutions, and temporary silicone Cap Forms. The allay™ Nerve Cap system is provided in a plastic tray sealed in a sterile, peelable outer pouch. The product is available in two sizes of a Small Nerve Set, for nerves less than 4 mm in diameter, and a Large Nerve Set, for nerves greater than 4 mm in diameter and less than 7 mm in diameter. The allay™ Nerve Cap system includes a Powder Vial/Vial Adapter, Diluent Solution, Acceleration Solution, Dual Applicator and Adapter, Delivery Tip with Blunt Needle, and the Cap Forms [Small Nerve Set (l, 2, 3, and 4 mm) and Large Nerve Set (5, 6, and 7 mm)]. As a convenience for users, Delivery Tips are also provided separately if needed. They are provided in boxes that consist of six independently packaged, sterile Delivery Tips. They are identical to the Delivery Tips provided in the complete allay™ Nerve Cap kit, including with respect to dimensions, materials, use, and manufacturing.

The allay™ Nerve Cap is a single use device that is provided sterile and is strictly for prescription (Rx) use only.

N/A

Ask a specific question about this device