Paradise® Ultrasound Renal Denervation System for HTN

Ultrasound renal denervation for hypertension

With 360° ablation technology and exclusive features designed to ensure a safe and effective procedure, the Paradise Ultrasound Renal Denervation (uRDN) system is designed to offer a proven therapy option to lower your patients’ blood pressure.^1-2

Read clinical evidence

Maximize performance.

With exclusive features designed to ensure a safe and effective procedure, the Paradise uRDN system offers a proven therapy option to lower your patients’ blood pressure.^1-3

The Paradise uRDN system treats hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause hypertension.

SonoWave 360™ Transducer

SonoWave 360™ transducer maximizes treatment zone with circumferential ablation, emitting ultrasound in 360° with no tissue contact.

HydroCooling™ System

Only the Paradise uRDN system provides energy delivery with no contact by the transducer, and the HydroCooling™ system circulates sterile water through the balloon during the procedure for a cooling effect that helps protect the arterial wall.²

Ultrasound Ablation

Ultrasound energy penetrates effectively at targeted depth of 6 mm to ablate sympathetic nerves around the main renal artery—all while staying in the main with no need to go into distal branches.

See if Paradise uRDN is right for your patient. Hear experts share their experience with the Paradise uRDN system.

See Important Safety Statement.

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Unlock efficiency.

Engineered with shorter ablation time and fewer ablations in total, as well as less fluoroscopy and less contrast volume⁴, delivering an experience that’s predictable while minimizing discomfort and risk for your patients.^{1, 4-7}

Stay in the main renal arteries without going into the distal branches^*,5
7 second per ablation, up to 2-3 ablations per artery^5,6
Less fluoroscopy and contrast volume⁷

Deliver lasting outcomes.

Sustainable reduction out to at least 3 years^8,9, and lasting, meaningful improvement for years to come.

6 months

GPS Registry (EMEA)

-19.6 mmHg office SBP reduction from baseline (Uncontrolled hypertension with baseline ≥ 140 mmHg, N=92)¹⁰

3 years

RADIANCE-HTN TRIO

-17.3 mmHg office SBP reduction from baseline (Resistant hypertension with baseline ≥ 150 mmHg, N=30)¹¹

8 years

ACHIEVE

-22.1 mmHg sustained office BP reduction from baseline (N=27)¹²

See more clinical evidence

References

*Treatment site may vary with anatomy. Please refer to Paradise Catheter IFU for treatment strategy.

Data on file.
Pathak et al. EuroIntervention. 2015 Aug;11(4):477-84
Data on file. Recor Medical; Anatomies may vary, see IFU.
Fengler et al. JACC: Cardiovascular Interventions. Vol 16. No. 3. 2023: 359-369.
Paradise® 6Fr Catheter IFU and Paradise® Generator Operator Manual IFU.
Symplicity Spyral™ Catheter Instructions for Use Manual Rev.(A)
Fengler et al. Circulation. 2019 Jan 29;139(5):590-600.
Bloch et al. Hypertens Res. 2024
V. Zeijen, ACHIEVE Study update. TCT 2023
Fengler, K., TCT 2025;580.
Bloch et al. Hypertens Res. 2024. (In patient population with baseline office SBP ≥ 150 mmHG)
Zeijen VJM Clin Res Cardiol. 2024.

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 >8 mm
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 insufficiency, 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 fistula, Arterio-venous fistula, 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).

Get more information about how Paradise Ultrasound RDN can help your patients control high blood pressure.

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