The Paradise™ Ultrasound Renal Denervation (RDN) System offers a high standard of therapy, harnessing the power of ultrasound energy to treat uncontrolled hypertension.

Hypertension remains a leading cause of cardiovascular issues, including heart failure, stroke, coronary heart disease, and more. And control rates around the globe are declining.

1.28B*

Adults globally

1 in 5*

Controlled

Paradise™ Ultrasound RDN treats hypertension by ablating the nerves around the renal arteries, disrupting the overactive sympathetic nerves that can cause hypertension.

*World Health Organization; https://www.who.int/news-room/fact-sheets/detail/hypertension; accessed on 7/09/2023

Designed to deliver.

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

SonoWave 360™ transducer

The Paradise™ system’s SonoWave 360 transducer delivers a complete 360-degree ring of energy4, reaching approximately 80 percent5 of the sympathetic nerves around the renal artery.

7-second energy delivery

Each delivery of ultrasound energy is just 7 seconds, and only 2-3 treatments per main renal artery are needed.* With the Paradise™ system, treating the distal branches is never required.4

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

HydroCooling™ system

Only the Paradise™ 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.6

Robust, durable results.

Deliver a lasting treatment for uncontrolled or resistant hypertension — proven safe and effective across several clinical trials.1-3,8

Off Medication

On Medication

Uncontrolled Hypertension

Uncontrolled
Hypertension

RADIANCE™ RCTs
combined results

–10.4mmHg

office systolic blood
pressure at 2 months ⁸

Met all primary
endpoints in

3/3

U.S. and Europe randomized
controlled trials ¹ ² ³

RADIANCE™ II
pivotal trial

Zero

Major Adverse Events
At prespecified follow-up

Made for efficiency.

State-of-the-art Catheter4

  • SonoWave 360 transducer
  • Non-compliant balloon with HydroCooling system
  • Atraumatic tip for patient safety

Intuitive Generator4

  • Simple, user-friendly interface with ultra-efficient workflow
  • Automatic energy level customized to the patient’s anatomy
  • Hand-held remote to perform procedure from sterile field

References

  1. Azizi et al. JAMA. 2023;329(8):651-661
  2. Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345.
  3. Azizi et al. Lancet. 2021 Jun 26;397(10293):2476-2486.
  4. Data on file. Recor Medical. Inc.
  5. Mahfoud et al. JACC. 2014; 64(7):644-646.
  6. Pathak et al. EuroIntervention. 2015 Aug;11(4):477-84
  7. Fengler et al. JACC: Cardiovascular Interventions,2023, Feb 13 :359-369
  8. Kirtane et al. JAMA Cardiol. 2023;8(5):464-473

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™ system is contraindicated for patients with any of the following:

Stented renal artery 2. Renal artery with stenosis of any origin >30% 4.Renal artery with Fibromuscular disease (FMD) 5.Renal artery with aneurysm 6. Iliac/femoral artery stenosis precluding insertion of the Paradise™ catheter 7.Pregnant 8. Less than 18 years of age 9.Known allergy to contrast medium

Warnings

  • Failure to use the recommended balloon size may result in renal artery 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 locations with visible plaque.
  • Do not deliver sonications in an overlapping configuration.

Precautions

  • Patients with known allergy to contrast medium should be appropriately treated.
  • Only use specified coolant (Sterile water) for fluid supply. DO NOT USE SALINE.
  • Avoid multiple inflations of the balloon 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 injury, illness, or death of the patient.
  • 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 Adverse Effects of catheterization procedures
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)

Risks of renal denervation procedure
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

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