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510(k) Data Aggregation
(75 days)
COAPTIUM® Connect with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.
COAPTIUM® Connect is a bioabsorbable coaptation system for sutureless peripheral nerve repair of peripheral nerves not in continuity. The system includes a single-use syringe pre-filled with a photoactive COAPTIUM® polymer, which is used to secure an implantable three-dimensional coaptation chamber to the nerve segments that are distal and proximal to a peripheral nerve injury.
The system includes implantable components, the coaptation chamber and the COAPTIUM® polymer, and three sterile disposable accessories: a silicone applicator (base and cap), a syringe tip, and a TISSIUM® Light Cover.
The coaptation chamber and the COAPTIUM® polymer are designed to serve as a protective interface between the peripheral nerve and the surrounding tissues over time and create a conduit for axonal growth across a nerve gap, without the use of sutures. They are soft and flexible and degrade through hydrolysis with a bioabsorption profile that is compatible with nerve healing.
The silicone applicator and syringe tip are designed to promote consistent and precise application of the COAPTIUM® polymer onto the coaptation chamber and adjacent peripheral nerve. The TISSIUM®
Light Cover is for use with the reusable TISSIUM® LIGHT, which polymerizes the COAPTIUM® polymer on-demand.
The components of COAPTIUM® CONNECT are supplied in single use sterile double peel packages and come in a variety of sizes. The TISSIUM® Light Cover is supplied in a single peel pouch and used as a sterile cover for the reusable TISSIUM® LIGHT.
The TISSIUM® LIGHT is supplied separately and packaged in a single wall corrugated cardboard box.
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(208 days)
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