Conversion to IDE

This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.

Inclusion Criteria:

• Age > 18 years
• Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
• Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
• Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

• Age <18 years old
• Patient unable to sign informed consent
• Patient participating in another investigational device or pharmacological study
• Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

Adult patients undergoing arteriovenous fistula creation for hemodialysis access

There was 1 screen fail.

1 year

This was designed as 2 Stage Study. Subjects were only enrolled into Stage 1 and the study has been terminated

One immunocompromised transplant subject experienced a potential local wound infection and the event was deemed to be possibly device related.

Two subjects passed away during the study. One was deemed not to be in relation to the study device. The second was deemed possibly related due to a sudden death within the thirty-day postoperative window.