Controlling And Lowering Blood Pressure With the MobiusHDTM Device

CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Inclusion Criteria:

• Aged 18-70 years;
• Diagnosed with resistant hypertension;
• A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
• A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion Criteria:

• Known or clinically suspected baroreflex failure or autonomic neuropathy
• Treatable cause of resistant hypertension
• Hypertension secondary to an identifiable and treatable cause other than sleep apnea