Overview

To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

Eligibility

Inclusion Criteria:

• Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.

Exclusion Criteria:

• Known or clinically suspected baroreflex failure or autonomic neuropathy

        Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study
        at one site (Universitair Medisch Centrum Utrecht)
        Inclusion Criteria:
        - Patients must be eligible for the main study and must have passed all CALM-DIEM study
        inclusion and exclusion criteria at time of screening
        Exclusion Criteria:
          -  Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that
             cannot be discontinued safely
          -  Underlying conditions that prohibit microneurography, performance of a Valsalva
             maneuver and/or magnetic resonance imaging