This is a brief overview of information related to the FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Paradise Ultrasound Renal Denervation System
PMA Applicant: Recor Medical, Inc.
Address: 1049 Elwell Court Palo Alto, CA 94303
Approval Date: November 7, 2023
Approval Letter: Approval Order

What is it?

Paradise Ultrasound Renal Denervation System is intended to reduce a person’s blood pressure by using ultrasound energy to disrupt nervous system signals to the kidneys. The device is intended for use to reduce blood pressure.

How does it work?

The Paradise Ultrasound Renal Denervation System delivers ultrasound energy to the nerves that lead to the kidney (the renal sympathetic nerves) using a catheter inserted in the largest artery in the leg (femoral artery) through a small incision in the patient’s groin. An external ultrasound generator creates an electrical signal that travels to the far end of the catheter, where a transducer converts the signal into ultrasound vibrations. The system heats the tissue around the nerves, while protecting the artery. End of
Translation Heating destroys a specific, controlled amount of tissue (thermal ablation) to disrupt nerve activity and achieve a reduction in the pressure put on arteries during heart contractions (systemic arterial blood pressure).

When is it used?

The Paradise Ultrasound Renal Denervation System is used together with lifestyle modifications and anti-hypertensive medications to reduce blood pressure in people with high blood pressure (hypertension).

What will it accomplish?

Renal denervation disrupts nerves that tell the body to increase blood pressure, which can lead to lower blood pressure. In three clinical studies in the United States, people treated with the Paradise Ultrasound Renal Denervation System experienced lower blood pressure through two months.

When should it not be used?

The Paradise Catheter should not be used in people with any of the following:

• Renal artery diameter less than 3mm and more than 8 mm
• Renal artery fibromuscular dysplasia (FMD)
• Stented renal artery
• Renal artery aneurysm
• Renal artery diameter narrowing (stenosis) more than 30%
• Pregnancy
• Presence of abnormal kidney (or secreting adrenal) tumors
• Iliac or femoral artery stenosis that prevents catheter insertion

Additional information (including warnings, precautions, and adverse events):  

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• PMA Database Entry