Give patients a new option for hypertension treatment

Use the power of ultrasound for sustained blood-pressure reduction1,2,3,4

Patients need an alternative

Hypertension isn’t just a number—it’s a silent, daily struggle. And for too many, today’s hypertension protocols fall short.5

Current first- and second-line treatments can be tough to maintain, especially with the challenge of lifestyle changes, complex medication regimens, serious side effects, and the mental toll of treatment fatigue. And for those with resistant hypertension, even multiple medications often aren’t enough.

Paradise™ Ultrasound RDN provides patients a new option. Let’s bridge the gap in hypertension care.

Patients need an alternative

Hypertension isn’t just a number—it’s a silent, daily struggle. And for too many, today’s hypertension protocols fall short.5

Current first- and second-line treatments can be tough to maintain, especially with the challenge of lifestyle changes, complex medication regimens, serious side effects, and the mental toll of treatment fatigue. And for those with resistant hypertension, even multiple medications often aren’t enough.

Paradise™ Ultrasound RDN offers suffering patients a new option. Let’s bridge the gap in hypertension care.

The benefits of Paradise™ Ultrasound
RDN treatment

Renal denervation (RDN) is a one-time, minimally invasive treatment that uses ultrasound energy to target overactive renal nerves, helping to lower blood pressure sustainably over time1,2,3,4

24H, sustained BP reduction1,2,3

Clinical studies show RDN delivers sustained, 24h reductions in blood pressure

No adherence challenges5,6

RDN removes the risk of missed medication doses and simplifies sustained hypertension management

No medicationrelated side effects1,2,3*

Offers blood-pressure control without the common side effects associated with antihypertensive drugs

Short ablation time**

Short 7-second ablations delivered in 2-3 times in each main renal artery

Most common adverse effects in clinical studies include pain, vascular access site complications and vasospasm. See complete important safety information at the bottom.

How Renal Denervation works

RDN targets overactive nerves in the walls of the renal arteries, which play a key role in regulating blood pressure. By using ultrasound energy to calm them, RDN helps reduce sympathetic nerve signals, potentially leading to a sustained drop in blood pressure. In clinical studies it has been proven to be effective in the presence of medication; effective in the absence of medication; effective in all measures of BP control.1,2,3,4

“Renal denervation is very safe…

… there are actually no major complications. About three quarters of patients respond to the procedure with a good reduction in blood pressure. If you are one of the patients who experience a reduction in blood pressure, you can also be sure that the reduction in blood pressure is relatively good.”

Dr. Karl-Philipp Rommel
Consultant in Cardiology at the Mainz University Medical Center.

Disclaimer: The interview features Dr. Rommel`s medical expertise sharing insights on renal denervation. Please note that the doctor was compensated for the time and effort involved in participating in this interview. The views and opinions expressed are those of the doctor and do not necessarily reflect those of Recor Medical or other experts.

CLINICAL EVIDENCE

Results that last. Evidence that bridges the gap.

Proven effective in 3/3 U.S. randomized controlled trials.1,2,3

Lasting, powerful results.1,2,3,4

Procedural protection and safety.7

Hypertension treatment is evolving
– are you up to date?

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  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 A. el al., JAMA Cardiol. 2023;8:464-473
  5. Worl Health Organization; https://www.who.int/news-room/fact-sheets/detail/hypertension; accessed on 11.01.2023
  6. Berra et. al Hypertension. 2016;98:297-306.
  7. Pathek et al. EuroIntervention. 2015;11477-84.

*Most common adverse effects in clinical studies include pain, vascular access site complications and vasospasm. See
complete important safety information.
**(Data on file) Treatment site may vary with anatomy. Please refer to Paradise Catheter IFU for treatment strategy.

The Paradise Catheter is indicated for percutaneous renal denervation.

The Paradise Catheter is contraindicated for patients with any of the following:

  • Renal arteries diameter < 3 mm and > 8mm
  • Renal artery with Fibromuscular dysplasia (FMD)
  • Stented renal artery
  • Renal artery aneurysm
  • Renal artery stenosis of any origin >30%
  • Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
  • Less than 18 years of age
  • Pregnant
  • Known allergy to contrast medium
  • 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, or no ablation of target tissue achieved.
  • 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,
  • 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 manufactureds 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, nausec, vomiting), Hypotension/ Dizziness and/or Headaches, Hypertension, Hyperhidrosis, Pain (transient abdominal, Iower 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.
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, plaxue), Hematuria, Infection, Myocardial infarction, Pain, Vascular access site complications (pseudoaneurysm, pain, swelling, hematoma).
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), Hypotensioní Diëëiness andíor 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.