SPYRAL GEMINI Pilot Study

Prior treatment

• Prior renal or hepatic denervation.

Other illness

• 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.
• Primary pulmonary arterial hypertension.
• History or evidence of active / suspected chronic liver or biliary disease.

Lab values

• Estimated glomerular filtration rate (eGFR) of \<40

Other

• Individual lacks appropriate renal artery OR common hepatic artery anatomy.
• Pregnant, nursing or planning to become pregnant during the study.
• Current or chronic pancreatitis.

• 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.