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Paradise® Ultrasound Renal Denervation (RDN) System

High blood pressure (hypertension) is a serious health issue that affects nearly half of all adults in the United States—and only 25% of those affected have their blood pressure under control. Managing hypertension is important because, if left untreated, it can lead to several life-threatening complications, including heart failure, heart attack, stroke, and kidney disease.

What Is the Relationship Between Kidney Function and Hypertension?

In addition to filtering the blood and eliminating waste in the form of urine, the kidneys play a key role in keeping blood pressure within a healthy range. Hypertension is frequently associated with overactive kidney (renal) nerves, which can increase blood pressure by promoting water and salt retention and releasing certain hormones.

How Are Overactive Renal Nerves Treated?

In patients with uncontrolled hypertension, renal denervation surgery can produce a clinically meaningful drop in blood pressure by calming overactive renal nerves. Approved by the U.S. Food and Drug Administration (FDA) for the treatment of high blood pressure, the Paradise Ultrasound Renal Denervation (RDN) system harnesses the power of ultrasound energy to disrupt hyperactive renal nerves. The world-class physicians in Tampa General Hospital’s Heart and Vascular Institute were among the first in the Tampa Bay region to offer this leading-edge peripheral intervention to lower blood pressure without medication.

When Is the Paradise Ultrasound RDN System Considered?

To manage high blood pressure, most experts recommend starting with lifestyle modifications, such as:

  • Quitting smoking
  • Drinking alcoholic beverages in moderation, if at all
  • Eating a nutritious diet low in red and processed meats
  • Exercising regularly
  • Maintaining a healthy body weight
  • Reducing stress

If necessary, a physician may also suggest a regimen of anti-hypertensive medications to complement these lifestyle changes.

Hypertension does not always respond to this first-line treatment approach, however, and some patients cannot tolerate certain anti-hypertensive medications. In these instances, renal denervation surgery may be considered.

How Does the Paradise Ultrasound RDN System Work?

The Paradise Ultrasound RDN system can lower blood pressure by desensitizing (ablating) overactive renal nerves. This innovative platform incorporates several exclusive features, including:

  • SonoWave™ 360 transducer – This advanced device allows for the delivery of a 360-degree ring of ultrasound energy that can reach up to 80% of the sympathetic nerves around the targeted renal artery.
  • Seven-second energy delivery – Only two or three seven-second doses of ultrasound energy are needed to treat each main renal artery.
  • HydroCooling™ system – During the renal denervation procedure, sterile water is continually circulated within a balloon, creating a cooling effect to protect the arterial wall.

How Is the Paradise Ultrasound RDN System Used?

The Paradise Ultrasound RDN system is used during a minimally invasive outpatient procedure, which generally involves:

  • Preparation – The patient will be prepared for the procedure and mildly sedated.
  • Access – An interventional cardiologist will make a small incision in the groin area to access the femoral artery.
  • Catheter insertion – The physician will insert a thin, flexible tube (catheter) through the incision and guide it into the targeted renal artery.
  • Ultrasound energy delivery – Once the catheter is in place, the physician will activate the transducer at the tip of the catheter and deliver the ultrasound energy to the renal artery wall.
  • Monitoring – Throughout the procedure, a medical team will continually monitor the patient’s blood pressure and other vital signs to ensure safety.
  • Completion – After the ultrasound energy delivery is complete, the physician will remove the catheter and close the incision.

What to Expect With the Paradise Ultrasound RDN System

The renal denervation procedure takes approximately one hour to complete. Most patients go home on the same day as their procedure and quickly resume their normal activities.

How Effective Is the Paradise Ultrasound RDN System?

The Paradise Ultrasound RDN system has shown promising effectiveness in reducing blood pressure in patients with resistant hypertension, a population for whom medication therapy is often insufficient. It can also be effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure. Clinical studies have demonstrated significant reductions in both systolic and diastolic blood pressure following treatment.

That said, the effectiveness of renal denervation surgery can vary widely based on the unique characteristics of the patient and their hypertension. It is important for patients who are considering this treatment to discuss the potential benefits and risks with their physician.

Benefit From World-Class Care at TGH

TGH’s Interventional Cardiology Center of Excellence is leading the way in bringing innovative solutions to patients who struggle to control their blood pressure. By changing the course of hypertension, we are changing the course of coronary disease and helping many patients achieve a better outcome and quality of life.

If you would like to learn more about the Paradise Ultrasound RDN system, contact us at (800) 822-3627 to request an appointment with a specialist on our team.