Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

Inclusion Criteria:

Subjects are eligible to participate if all of the following criteria are met:

1. Aged ≥22 and ≤80 years old at time of enrollment (consent).

2. Diagnosed with resistant hypertension.

3. Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensivemedications of different classes including a diuretic for at least 4 weeks prior toconsent.

4. Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.

5. Agrees to have all study procedures performed, and is competent and willing toprovide written, informed consent to participate in this clinical study.

Exclusion Criteria:

Subjects are not eligible to participate if any of the following criteria are met:

1. Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.

2. Has one or more of the following conditions:

3. Unstable angina with stent implantation (percutaneous coronary intervention)within 3 months of enrolment.

4. Myocardial infarction within 3 months of enrollment.

5. Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 monthsof enrollment

6. Cerebrovascular accident or transient ischemic attack within 3 months ofenrollment.

7. Atrial fibrillation patients undergoing treatment and not in sinus rhythm.Notes: Patients who have received medical treatment, catheter or surgicaltreatment for atrial fibrillation and are in sinus rhythm are not excluded

8. Has one or more of the following confirmed anatomical findings in the kidney orrenal artery that are not suitable for renal denervation (assessed by the renal CTangiography of Screening 2)

9. A single functioning kidney.

10. An atheroma, aneurysm or renal artery stent within 5 mm of the renaldenervation site.

11. Presence of stenosis of 30% or more on all of the blood vessels available forrenal denervation therapy.

12. When it is deemed impossible to perform denervation on both renal arteriesaccording to the discretion of the investigator.

13. Has one or more of the following medical history or a history of surgery/procedurethat is not suitable for renal denervation therapy

14. Renal denervation therapy.

15. Polycystic kidney disease (PKD).

16. Atrophic kidney.

17. Kidney transplant.

18. Dialysis due to end-stage renal disease.

19. Any surgery performed on both kidneys.

20. FMD (Fibromuscular dysplasia)

21. Has comorbidities or surgical/procedural history that are not suitable forretroperitoneal approach

22. Surgical history through retroperitoneal approach.

23. Fibrosis in the retroperitoneal region.

24. Inflammation in the retroperitoneal region.

25. Severe obesity (body mass index (BMI) > 40 kg/m2)

26. Risk of increased intracranial pressure

27. Has a history of any intervention for underlying renal artery pathology includingstenting or balloon angioplasty.

28. Individual has an eGFR of <60 mL/min/1.73m2, using the 4 variable Modification ofDiet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x SerumCr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if female).

29. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%).

30. Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes ofstanding coupled with symptoms during the screening process (at Screening Visit 2).

31. Requires chronic oxygen support or mechanical ventilation other than nocturnalrespiratory support for sleep apnea (e.g., CPAP, BiPAP).

32. Has documented primary pulmonary hypertension.

33. Has an untreated secondary cause of hypertension (either known or suspected) or istaking drugs that increase sympathetic tone and could contribute to hypertension.

34. Has a scheduled or planned surgery that, in the opinion of the Investigator, mayaffect study endpoints.

35. Works night shifts.

36. Has severe cardiac valve stenosis for which, in the opinion of the Investigator, asignificant reduction of blood pressure is contraindicated.

37. Is pregnant, nursing or planning to become pregnant during the course of the studyfollow-up (Note: Female participants of childbearing potential must have a negativeserum or urine human chorionic gonadotropin (hCG) pregnancy test prior toangiography).

38. Has a known unresolved history of drug use or alcohol dependency, lacks the abilityto comprehend or follow instructions, or would be unlikely or unable, in the opinionof the Investigator, to comply with study follow-up requirements.

39. Has a history of bleeding diathesis or coagulopathy or will refuse bloodtransfusions.

40. Patients who are at high risk if taken off their anticoagulant and antiplateletagents for a few days.

41. Allergy, intolerance or contraindications to contrast medium.

42. Prescribed any standard antihypertensive cardiovascular medication for other chronicconditions (e.g. ischemic heart disease) for less than 90 days before Screeningvisit 1 and whose discontinuation might pose serious risk to health.

43. Has frequent intermittent or chronic pain that results in the treatment withnon-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per weekover the month prior to Screening Visit 2.

44. Concurrent enrollment in any other investigational drug or devicestudy(Participation in non-interventional Registries is acceptable).