Referral Group
It’s not another pill, It’s another way.
New 2025 AHA/ACC guideline include
Renal Denervation as an option to lower blood pressure.
The 2025 American Heart Association Guideline1 recognizes Renal Denervation (RDN) as an adjunct therapy for appropriately selected patients with uncontrolled or resistant hypertension.
When RDN may be considered.
- Patients with stage 2 hypertension (office SBP ≥140 mmHg and DBP ≥90 mmHg) who are unable to take antihypertensive medications at the optimal dosages or additional medication
- Patients with stage 2 hypertension in whom BP is not at goal despite taking ≥4 antihypertensive medications and eGFR ≥40 mL/min/1.73 m2 at optimal dosages (ACEi/ARB + CCB + thiazide-type diuretics, and MRA)
Learn more about AHA/ACC guidelines and patient selection.
Take control—check if the Paradise uRDN procedure is right for your patients.
- Patients who have elevated blood pressure despite 3 or more medications.
- Patients who are on multiple medications and have documented non-adherence/intolerance.
- Patients who have history of or at high risk of cardiovascular events.
- Patients who may have a history of hypertensive crisis.
Learnings from a real conversation with Dr. Brown: her insights from clinical practice on patient selection criteria for Renal Denervation.
Experience a new path to lowering blood pressure.
Drive to blood pressure goal.
Paradise Ultrasound RDN procedure treats hypertension by calming the overactive renal nerves. When medications and lifestyle changes are not enough, it delivers safe and sustained reductions proven across multiple sham-controlled trials.2-5
The Paradise uRDN procedure works by delivering ultrasound energy to renal arteries to disrupt overactive sympathetic nerves, reducing nerve signaling that contributes to high blood pressure.
It is a short procedure and is not an implant. Patients go back to referring physicians for follow-up.
Works 24-hours.
Transforming uncontrolled resistant hypertension with
24-hour reduction, a meaningful blood pressure drop at 6 months, sustainable improvement for years to come.2-6
RADIANCE-HTN Pooled Analysis
A proven approach to managing hypertension.
Patients with resistant hypertension struggle to reduce blood pressure due to poor adherence to medication, side effects, and lack of response to medications
-19.6 mmHg
EMEA GPS real world data
Office SBP reduction from baseline prospective at 6 months, uncontrolled HTN patients (OSBP ≥ 140 mmHg, N=92)7
-17.3 mmHg
RADIANCE TRIO (on-med study)
Office SBP reduction from baseline8,*,** , Resistant HTN** Baseline Office SBP ≥150, mmHg at 3 years (N=30)
* In patient population with baseline office SBP 150 mmHg.
** Baseline measurement occurred following 4-week standardization on a
3-drug single-pill.
Trust in Proven Safety
A one-time, minimally invasive, outpatient procedure delivering meaningful blood pressure reductions.2-6 Proven safe with no impact to kidney function,9 and without side effects of drugs
ZERO
major adverse events in the pivotal trial5
NO
impact on renal function at 2 months2
ZERO
clinically significant renal arterial stenosis at 6 months2
Get a free digital copy of the Paradise uRDN therapy brochure
Deliver lasting outcomes.
Sustainable reduction out to at least 3 years2-6,8, and lasting, meaningful improvement for years to come.
6 months
GPS Registry (EMEA)
-19.6 mmHg office SBP reduction from baseline in combination with medication therapy (Uncontrolled hypertension with baseline ≥ 140 mmHg, N=92)7
3 years
RADIANCE-HTN TRIO
-17.3 mmHg office SBP reduction from baseline (Resistant hypertension with baseline ≥ 150 mmHg, N=30)8
8 years
ACHIEVE
-22.1 mmHg sustained office BP reduction from baseline (N=27)10
References
- Jones D, et all, Hypertension, https://doi.org/10.1161/HYP.0000000000000249
- Kirtane A. et al. JAMA Cardiol. 2023;8(5):464-473
- Azizi M. et al. Lancet. 2018 Jun ;391(10137):2335-2345.
- Azizi M. et al. Lancet. 2021 Jun 26;397(10293):2476-2486.
- Azizi M. JAMA. 2023;329(8):651-661.
- Zeijen VJM Clin Res Cardiol. 2024.
- Fengler K. TCT-580. Presented at TCT 2025; October 2025
- Bloch et al. Hypertens Res. 2024.
- Redar et al. EuroIntervention 2022;18-online
- Zeijen VJM Clin Res Cardiol. 2024.
* 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)
© 2025 Recor Medical, Inc. All rights reserved. RECOR MEDICAL, PARADISE, RADIANCE, HYDROCOOLING, SONOWAVE 360 are trademarks of Recor Medical, Inc. The Paradise® System is FDA approved for sale in the United States, is CE marked and approved for sale in markets where the CE mark is accepted per approved indications for use, and received manufacturing and marketing approval in Japan.