A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.

Inclusion Criteria:

• Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
• Adult (age >18 years old).
• Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
• Written informed consent obtained