Important Safety Information
The Paradise™ blood pressure procedure was approved by the FDA in 2023 and to earn FDA approval, we conducted 3 rigorous randomized controlled trials in the U.S. All 3 clinical trials demonstrated that the Paradise procedure could effectively and safely lower blood pressure.1-3
However, like any medical procedure, it’s important to review all benefits, risks, and safety information with your doctor before deciding to move forward with the Paradise procedure.*
Patient experiences with the Paradise blood pressure procedure vary by individual. Only a doctor can determine if the Paradise procedure is right for you. Below is a brief summary.
Consult with your physician and see the full safety information below. Refer to instructions for use for full indication, contraindications, warnings and precautions details.
Who is the Paradise Procedure for?
The Paradise procedure is approved by the FDA as a complementary treatment to help lower blood pressure for people with hypertension who haven’t been able to successfully control their blood pressure with lifestyle changes and medications.
Who is not a candidate for the Paradise Procedure?
The Paradise procedure is not right for you if:
- You haven’t been diagnosed with hypertension
- You are able to successfully control your blood pressure with lifestyle changes and medications
- You have been diagnosed with renal artery fibromuscular disease
- You have a stent placed in your renal artery
- You have a renal artery aneurysm
- You are pregnant
- You have abnormal kidney (or secreting adrenal) tumors
- You are less than 18 years of age
- You have a known allergy to imaging solution
Additionally, at the time of your procedure, your doctor may find structural conditions related to the artery anatomy that would not allow your doctor to continue with the procedure, such as if the groin, femoral, or renal artery where your doctor will insert the catheter is too narrow. If you have a pacemaker or another active implanted medical device, your doctor will work with you, the device manufacturer, and/or the doctor who implanted your pacemaker or other active medical device to decide if the Paradise procedure is right for you and what precautions will need to be taken.
Your doctor will evaluate you and work with you to determine if the Paradise procedure is right for you. You may also need other testing, verification of insurance coverage benefits, or insurance pre-approval before deciding next steps.
What are the potential risks of the Paradise procedure?
Below are the potential risks you should know about that can happen during the Paradise procedure or after getting the Paradise procedure. Below are the most common potential risks with the Paradise procedure or response to the treatment:
- Pain or discomfort
- Complications at the site where the catheter is inserted (like bleeding, bruising or swelling, etc.)
- Narrowing or tightening of the arteries (renal artery spasm) that often resolves on its own. These types of events are generally expected with any kind of minimally invasive procedure, and almost all of them are resolved on their own or with medication.
The rare but more serious potential risks that may occur as response to the treatment or to the catheterization procedure include:
- Abnormal connection between two anatomical structures (artery and vein or the aorta and gastrointestinal tract)
- Allergic reaction to contrast (sensitivity to the solution used for imaging arteries)
- Anxiety
- Pockets of blood that develop from a blood vessel wall injury
- Blood flow blockage to your kidneys
- Blockage in the arteries to the lungs, kidney or other blood vessels
- Blood clots in deep veins
- Narrowing of the artery that progresses over time (renal artery stenosis)
- Blood in urine
- Cardiac arrest or heart attack
- Chest pain or discomfort
- Complications related to pain and anti-anxiety medications provided
- Death
- Dizziness or headaches
- Diarrhea, nausea, or vomiting
- Excessive sweating
- Infection
- Irregular heartbeat or abnormal heart rhythm
- Kidney damage that may cause one or both of kidneys to stop working
- Low or high blood pressure
- Slow heart rate or fast heart rate
- Thermal injuries to the tissue neighboring your renal arteries (vessels, nearby tissue and/or other structures)
- Stroke or transient ischemic event “mini stroke”
- Swelling
What should I tell my healthcare provider?
Please inform your physician of all symptoms, conditions, interventions and treatments you take for all conditions including prescription, over the counter medications and herbal supplements; if you are pregnant or planning to become pregnant, if you are breastfeeding or planning to breastfeed.