PAVmed CarpX Device Clinical Study

This is a prospective, single center, single arm, study of the CarpX device for treatment of carpel tunnel syndrome. Patients will be followed for up to 30 days post procedure.

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