PAVmed CarpX Device Clinical Study

Inclusion Criteria: * Patient is \> 18 years old * Patient is scheduled to undergo carpal tunnel release surgery * Patient has failed to respond to conservative treatment of CTS * CTS confirmed by strong clinical signs and positive Nerve Conduction Velocity (NCV) test * Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures Patient is willing and able to complete follow-up requirements Exclusion Criteria: * Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand that is unrelated to carpal tunnel syndrome. * Patient with stiff wrist, suspected space occupying lesions or other anatomic abnormalities of the forearm, wrist or hand or other concerns related to patient anatomy such as small wrist and/or thin skin * Prior invasive treatment of the hand or wrist for disease processes such as De Quervain's syndrome, arthritic wrist etc. on the intended treatment side * Previous trauma/fracture or other anatomic abnormalities of the forearm, wrist or hand on the intended treatment side * Patient has an ipsilateral injury or other conditions affecting hand function * Patient has acute CTS resulting from an injury (e.g., fracture) * Patient has had previous CTR surgery on the affected hand * Patient has severe chronic median nerve neuropathy shown by the EMG and NCS that shows denervation of the thenar muscle * Active local or systemic infection * Known allergy to any device component * Known severe allergy to contrast reagent that cannot be managed with premedication * Any significant medical condition(s) that would place patient at excessive risk for surgery such as: known bleeding disorder including thrombocytopenia (platelet count \< 80,000), thrombasthenia, hemophilia or Von Willebrand's disease, unstable cardiac disease, renal failure or uncontrolled diabetes * Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from fully participating * Women who are pregnant