BAROSTIM NEO Hypertension Pivotal Trial

BAROSTIM NEO Hypertension Pivotal Trial

The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

• Office Cuff Blood Pressure
• Physical Assessment
• Subject Medications
• Serious adverse events

Inclusion Criteria:

• Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
• Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

• Treating physician decision that the subject should not continue with therapy.