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 toparticipate in the study, prior to any study mandated procedures Patient is willingand able to complete follow-up requirements

Exclusion Criteria:

• Patient has a prior or current musculoskeletal or neurologic condition that limitsstrength, motion, or sensation in the affected hand that is unrelated to carpal tunnelsyndrome.

• Patient with stiff wrist, suspected space occupying lesions or other anatomicabnormalities of the forearm, wrist or hand or other concerns related to patientanatomy such as small wrist and/or thin skin

• Prior invasive treatment of the hand or wrist for disease processes such as DeQuervain's syndrome, arthritic wrist etc. on the intended treatment side

• Previous trauma/fracture or other anatomic abnormalities of the forearm, wrist or handon 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 showsdenervation 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 forsurgery such as: known bleeding disorder including thrombocytopenia (platelet count < 80,000), thrombasthenia, hemophilia or Von Willebrand's disease, unstable cardiacdisease, renal failure or uncontrolled diabetes

• Patient has other medical, social or psychological problem that in the opinion of theinvestigator precludes them from fully participating

• Women who are pregnant