Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Exclusion Criteria

• •CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.
• •Subject has history of Steal Syndrome.
• •Subject who is immunocompromised or immunosuppressed.
• •Subject has had three previous failed AV fistulae for hemodialysis access.
• •Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
• •Known or suspected active infection on the day of the index procedure.
• •Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula.
• •Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.
• •Subjects with active malignancy.
• •Subjects with a history of poor compliance with the dialysis protocol.
• •Subjects with a known or suspected allergy to any of the device materials.
• •Subjects with an existing fistula or graft.
• •Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
• •Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.