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The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.

The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear. It is intended to be a long term, single use implant. Implantation of the device by the surgeon produces a contour to reconstruct the patient's outer ear feature. A surgically created "pocket" at the implantation site is made by the surgeon for placement of the device (typically placed on the skeletal feature below the soft muscle tissue). The ePTFE-Coated Auricular is composed of a silicone elastomer core with an outer layer of ePTFE (expanded polytetrafluoroethylene) and is shaped approximately to that of the external ear. The implant comes in nine sizes and the surgeon has the option to trim the implant to fit the patient's need. The implant is provided sterile or non-sterile, as either the "Left" or "Right" side.