Access Cannulation Trial II

Inclusion Criteria

• •Inclusion:
• •1. The subject's AVF is deemed uncannulatable because:
• •1. The subject's anticipated cannulation zone(s) is/are \>6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to device implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for device placement):
• •* Arterial/Pull Zone: \_\_\_\_\_ mm deep
• •* Venous/Push Zone: \_\_\_\_\_ mm deep
• •OR
• •2. The subject's dialysis unit (which includes an experienced cannulator) attests that repeated cannulation is not achievable in their clinic due to one of the following:
• •* Failed access attempt in a fistula that was previously approved for cannulation, or
• •* Unable to palpate the fistula such that cannulation is not possible without patient risk.
• •2. The access surgeon caring for the subject attests that the device is likely to be at least equivalent to other methods (such as venous transposition or suction-assisted lipectomy) that could make the AVF easier to access and reduce risk of cannulation infiltrations.
• +30 more criteria