Clinical Evidence

Paradise® Ultrasound Renal Denervation is designed to set a new standard in hypertension treatment

Paradise Ultrasound Renal Denervation (uRDN) has been tested and proven effective across multiple clinical trials, including Recor’s RADIANCE™ global program and the ACHIEVE study. With statistically significant and durable results1–4, the Paradise System can offer a new, clinically meaningful therapy option for you and your patients.

Drive to blood pressure goal.

-10.4

mmHg

Reduction in office systolic blood pressure from baseline at 2 months in radiance pooled randomized controlled trial.4

-17.7

mmHg

Reduction in office systolic blood pressure from baseline at 3 years in RADIANCE SOLO (off-med study).5

works

24

hours

Reduction in blood pressure.1–4

Triple-tested, clinically validated.

The RADIANCE global program.

Through the successful RADIANCE global program, the Paradise System became the only renal denervation (RDN) modality to meet its primary efficacy endpoint in 3 out of 3 separate powered, randomized controlled trials (RCTs) in the U.S., and the only RDN system to prove efficacy in resistant hypertension via a controlled trial.3,8

RADIANCE-HTN TRIO3

Resistant hypertension
4-week, 3-drug combo pill stabilization

Recor Medical RADIANCE-HTN TRIO, Resistant hypertension

-4.5 mmHg, p=0.022

RADIANCE-HTN SOLO2

Off-med: mild to moderate hypertension
4-week anti-HTN medication washout

Recor Medical RADIANCE-HTN-SOLO, Off-med: mild to moderate hypertension

-6.3 mmHg, p=0.0001

RADIANCE II1

Off-med: mild to moderate hypertension
4-week anti-HTN medication washout

Recor Medical RADIANCE II, Off-med: mild to moderate hypertension
-4.5 mmHg, p<0.0001

Paradise uRDN

Sham

Deliver lasting outcomes.

3

years

Demonstrated substantial systolic blood pressure drop at 36 months in the only true resistant HTN study.6

8

years

Sustained blood pressure reduction out to 8 years.8

>10 mmHg blood pressure reduction. Less ablation time.8,9

RADIOSOUND-HTN*9,10 trial

Randomized head-to-head comparison of Ultrasound RDN and Radiofrequency RDN

With short 7-second bursts of ultrasound energy and 2–3 treatments in each main renal artery**11, Paradise Ultrasound RDN delivers meaningful reductions in blood pressure while shortening fluoroscopy time and reducing contrast load.9,10

*RADIOSOUND-HTN study enrollment period: 2015-2018. Antihypertensive medications remained stable through 6 months unless indicated by symptomatic hypo- or hypertension.
**Treatment site may vary with anatomy. Please refer to Paradise Catheter IFU for treatment strategy.

Resources

Primary endpoint publications

RADIANCE-HTN TRIO

Resistant hypertension

Read clinical trial

RADIANCE-HTN SOLO

Off-med: mild to moderate hypertension

Read clinical trial

RADIANCE II

Off-med: mild to moderate hypertension

Read clinical trial

Reference

  1. Azizi M. et al., JAMA. 2023;329:651-661.
  2. Azizi M. et al., Lancet. 2018;391:2335-2345.
  3. Azizi M. et al., Lancet. 2021;397:2476-2486.
  4. Kirtane et al. JAMA Cardiol. 2023;8(5):464-473.
  5. Rader et al. EuroIntervention.2022;18:e677-e685.
  6. Bloch et al. Hypertens Res. 2024.
  7. Kirtane et al. TCT2022
  8. V. Zeijen, ACHIEVE Study update. TCT 2023
  9. Fengler et al., Circulation. 2019;139:590-600.
  10. Fengler et al., JACC Cardivasc Interv. 2023;16:367-369.
  11. Data on file.

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
when used as an adjunctive treatment for hypertension may help your hypertension patients reduce blood pressure when lifestyle modifications and antihypertensive medications are not enough.

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