Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension

A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.

Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery.

Following implantation of the device, subjects will be followed for 60 months.

Inclusion Criteria:

1. Age 21 years or above
2. End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure
3. Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes
4. Deemed an acceptable candidate for the implant procedure by the investigator
5. Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography

Exclusion Criteria:

1. Known or clinically suspected baroreflex failure or autonomic neuropathy
2. History of intradialytic hypotension within the past 3 months
3. Secondary cause of hypertension except treated obstructive sleep apnea syndrome
4. BMI ≥ 45 kg/m2
5. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex