SPYRAL GEMINI Pilot Study

This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts:

• Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and,
• Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds

There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).

Inclusion criteria

All Subjects (both cohorts):

• ≥18 and ≤80 years of age.
• Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and <180 mmHg and an office DBP ≥ 90 mmHg.
• 24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.

Exclusion criteria

• Individual lacks appropriate renal artery OR common hepatic artery anatomy.
• Prior renal or hepatic denervation.
• History of NYHA Class III or IV heart failure within 6 months of screening visit.
• Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
• Documented Type 1 diabetes or use of insulin within 6 months.
• Secondary cause of hypertension.
• Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
• Estimated glomerular filtration rate (eGFR) of <40
• Pregnant, nursing or planning to become pregnant during the study.
• Primary pulmonary arterial hypertension.
• History or evidence of active / suspected chronic liver or biliary disease.
• Current or chronic pancreatitis.