PATIENT SELECTION

Identifying patient types

Profiles of hypertension patients who may be eligible for Paradise Ultrasound Renal Denervation (uRDN) treatment.

For Health Care Professional educational purposes only.

Is the Paradise uRDN treatment right for your patients?

Paradise uRDN treatment candidates may include a range of patients like the ones listed below*:

Ones who have tried all other options

Patients who been unsuccessful on a number of different meds (despite compliance and lifestyle adjustments), and who may have already been treated with beta blockers and spironolactone or other potassium-sparing diuretics

67 year-old male; uncontrolled hypertension on 5+ meds with coronary artery disease

History
  • Type II diabetes x 10 years
  • Coronary artery disease S/P non-STEMI 2003 s/p angioplasty and stent to mid LAD (no other significant obstruction), Echo: EF 45%, LVH
  • Social history: 21 pack-year, quit 20 years ago, no alcohol, no illicit drug use

  • Family history: hypertension, diabetes, colon cancer

 
Medications

Adherent to treatment; Olmesartan/HCTZ 100 mg/25 mg QD, Metoprolol XL 100 mg QD, Amlodipine 5 mg daily (cannot tolerate higher dose dt edema), Atorvastatin 80 mg QD, Metformin, ASA.

 
Physical Exam and labs:
  • Office BP: 152/87 mm Hg; Afebrile
  • Ambulatory BP monitoring: daytime 146/82 mm Hg,  nighttime 138/78 mm Hg
  • Home BP monitoring: 158/84 mm Hg (average over 7 days)
  • BMI – 32, gained 15 lbs over past 2 years
  • eGFR 46 mL/min/1.73 m2 
  • Urine albumin-creatinine ratio 52 mg/g
Clinical challenge

Patient is at risk for because of existing cardiovascular diseases, Secondary hypertension causes excluded including primary aldosteronism, pheochromocytoma, and renovascular disease.

Patient criteria and therapy decision

Patient is a candidate for the Paradise uRDN treatment as he has high cardiovascular risk associated with his medical and family history.

 

Ones who are resistant to drugs

Patients with resistant hypertension who have not met optimal BP with medications and lifestyle changes (no secondary causes and appropriate renal arteries); Patients that are on 3+ medications and are still elevated.

68 year-old female; resistant hypertension with 8+ medications

History
  • Hypertensive for 5+ years
  • Social history: never smoked and uses little alcohol
  • Family history of HTN and Stroke
Medications 
Clonidine patch 0.2, Bumetanide 1 (2x per week), Azilsartan 80, 21 medications attempted but cannot achieve control, non-adherent to medication; no known allergies.
Physical Exam and labs:
  • Obesity (BMI 35 kg/m2) Ambulatory BP monitoring: daytime 155/82 mm Hg, nighttime 163/90 mm Hg
  • Normal kidney function (eGFR and urine albumin-creatinine ratio)
Clinical challenge

Patient is at risk for cardiovascular diseases, has tried 5L/6L incl. Spironolactone hypertension treatment. Secondary hypertension workup excluded primary aldosteronism, pheochromocytoma, and renovascular disease.

Patient criteria and therapy decision

Patient is a candidate for the Paradise uRDN treatment because of failure to achieve control with multiple medications, non-adherence and high risk of cardiovascular disease.

 

Ones who cannot tolerate medications

Patients who cannot tolerate medications, including ACEs, ARB, CCB and Thiazides

55 year-old male; uncontrolled hypertension with intolerance to medication

History
  • Hypertensive for 10+ years. Hospitalized multiple times on hypertensive emergencies
  • Episodes of epistaxis, headache, and occasional palpitations
  • Social history: never smoked and uses little alcohol Physically fit and exercises intermittently. His mother has hypertension, but his siblings do not
Medications
Lisinopril 10 mg, once daily, and nifedipine 120 mg/day, extended-release, once daily by his physician. Adherence unknown.
Side effects
Hydrochlorothiazide interfered with his sexual function, and beta blockers made him feel “sluggish mentally.” He tried acupuncture but found it unhelpful.
Physical Exam and labs:
  • Office BP: 155/105 mm Hg; HR 80 bpm; RR 11; Afebrile
  • Obesity (BMI 32 kg/m2)
  • Ambulatory BP monitoring: daytime 150/92 mm Hg, nighttime 153/85 mm Hg
  • Highs in 240/180 leading to hypertensive emergencies.
  • Normal kidney function (eGFR and urine albumin-creatinine ratio)
  • Cardiac exam revealed a grade 2/6 holosystolic murmur at the base
  • Chest film revealed mild cardiomegaly, with left ventricular predominance, as well as a tortuous or dilated ascending aorta, for which further evaluation was scheduled
Clinical challenge

Patient cannot tolerate medications due to side effects. He already has cardiovascular diseases, and his level of adherence is unknown. Secondary hypertension workup excluded primary aldosteronism, pheochromocytoma, and renovascular disease.

Patient criteria and therapy decision

Patient is a candidate for the Paradise uRDN treatment as the patient has intolerance to multiple medications and is there fore not able to achieve optimal blood pressure control.

 

Ones who are not adherent

Patients with elevated blood pressure with different medications and have documented non-compliance

52 year-old female; uncontrolled hypertension with 4+ medication with documented non-adherence

History
  • Multiple ER visits and hospitalizations for hypertension urgency
  • Hospital records note possible non-adherence to medications
  • Social history: cigarette smoker
  • Family history: hypertension, coronary artery disease, heart failure
Medications
Labetalol 600 mg BID, HCTZ 25 mg QD, Lisinopril 40 mg QD, Norvasc 5 mg QD; has documented non adherent to medication.
Physical Exam and labs:
  • Office BP: 170/105 mmHg; HR 73 bpm; RR 11; Afebrile
  • Obesity (BMI 35 kg/m2)
  • Ambulatory BP monitoring: daytime 160/92 mmHg, nighttime 153/85 mmHg
  • Normal kidney function (eGFR and urine albumin-creatinine ratio
Clinical challenge

Patient cannot tolerate medications due to side effects. He already has cardiovascular diseases, and his level of adherence is unknown. Secondary hypertension workup excluded primary aldosteronism, pheochromocytoma, and renovascular disease.

Patient criteria and therapy decision

Patient is a candidate for the Paradise uRDN treatment as the patient has intolerance to multiple medications and is there fore not able to achieve optimal blood pressure control.

 

Learn more about the Paradise uRDN treatment

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*Case descriptions are for educational purposes only; not real patient cases. There are additional factors to consider to determine if Paradise uRDN is right for your patients and may require shared decision making with a team of medical specialists to assess risks and benefits. See Important Safety Information below. Refer to the IFU for more information prior to considering the Paradise uRDN treatment.

 

 

 

Important Safety Information

Rx Only. Brief Summary – Prior to use, please reference the Instructions for Use

Indications for Use

The Paradise Ultrasound Renal Denervation System (Paradise System) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.

Contraindications

• The Paradise Catheter is contraindicated in any of the following:

• Renal arteries diameter <3 mm and >8mm

• Renal artery Fibromuscular disease (FMD) Stented renal artery

• Renal artery aneurysm

• Renal artery diameter stenosis >30%

• Pregnancy

• Presence of abnormal kidney (or secreting adrenal) tumors

• Iliac/femoral artery stenosis precluding insertion of the catheter

Warnings

  • Failure to use the recommended balloon size may result in renal artery stenosis, dissection, perforation, aneurysm, significant vasospasm requiring intervention, ablation of unintended tissues or structures, and/or no ablation of target tissue achieved.

  • Energy emission in an unintended location may result in unintended tissue damage.

  • Do not move the Paradise Catheter during sonication.

  • Do not sonicate in renal artery at locations with visible plaque.

  • Do not deliver sonications in an overlapping arterial target zone.

Precautions

  • Patients with known allergy to contrast medium may be at increased risk of hypersensitivity reactions.

  • Only use specified coolant (Sterile water) for fluid supply. DO NOT USE SALINE.

  • Avoid multiple balloon inflations to achieve apposition of the balloon to the renal artery wall; multiple balloon inflations may result in increased vessel trauma.

  • The Paradise Catheter is for single use only. Do not resterilize or reuse. Reuse, reprocessing, or resterilization will compromise device integrity which may result in patient injury, illness, or death. Do not touch the Paradise Catheter balloon during sonication, as it may result in serious injury.

  • The Paradise System may interfere with or adversely affect the operation of cardiac pacemakers or other active implants, unless proper precautions have been taken or managed per the manufacturer’s instructions. When in doubt regarding possible hazards, seek qualified advice and/or consult with the manufacturer(s) prior to initiating a procedure. The Paradise Catheter is a Type CF, defibrillation-proof Applied Part.

Potential risks of renal denervation procedure/response to treatment

Ablation or thermal injury to vessel, adjacent tissue or other structures, Acute kidney injury, Angina, Anxiety, Arrhythmia, Atrial tachycardia, Bradycardia, Gastrointestinal complications (diarrhea, nausea, vomiting), Hypotension/ Dizziness and/or Headaches, Hypertension, Hyperhidrosis, Pain (transient abdominal, lower back), Renal failure or renal insufciency, Renal artery aneurysm or pseudoaneurysm, Renal infarction, Renal artery dissection, or perforation, Renal artery stenosis, Vasospasm, Vasovagal response, Stroke or transient ischemic event

Potential risks of arterial catheterization procedure

Allergic reaction to contrast, Arterio-enteric fifistula, Arterio-venous fifistula, Bleeding, Cardiopulmonary arrest, Complications related to pain and anti-anxiety medications, Death, Deep vein thrombosis, Edema, Embolism (pulmonary, renal, peripheral vasculature, plaque), Hematuria, Infection, Myocardial infarction, Pain, Vascular access site complications (pseudoaneurysm, pain, swelling, hematoma