Controlling and Lowering Blood Pressure With the MobiusHD™

Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers

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

The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

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