Spyral InSight Study

Spyral InSight Early Clinical Feasibility Study

The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.

This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months.

There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows:

• To assess safety of RNS when performed prior to and post RDN.
• To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.

Inclusion Criteria:

1. 20 - 70 years of age
2. Office SBP ≥150 mmHg and <180 mmHg and DBP ≥90 mmHg
3. Individual is prescribed with one, two, or three antihypertensive medication classes
4. 24-hour ABPM average of SBP ≥135 and <170 mmHg at Baseline

Exclusion Criteria:

1. Prior renal denervation.
2. Individual lacks appropriate renal artery Anatomy
3. Has a renal artery stent
4. Individual has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2
5. Individual is taking SGLT2 inhibitors or GLP-1 agonists
6. Individual requires chronic oxygen support or mechanical ventilation
7. Primary pulmonary hypertension.
8. Secondary cause of hypertension
9. Pregnant, nursing or planning to become pregnant during the study.
10. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
11. Individual is currently taking anti-mineralocorticoid drugs.