Following approval from the U.S. Food and Drug Administration on Nov. 7, Cleveland Clinic used a first-of-its-kind ultrasound-based renal denervation on a patient. The Paradise system, created by Recor, works to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries. The system delivers two to three doses of 360-degree ultrasound energy through the main renal arteries to the surrounding nerves, reducing overactivity that fuels hypertension. The system is also water-cooled to protect the renal artery wall.
Uncontrolled or resistant hypertension is when your blood pressure remains high or unmanaged, despite taking medications. People with hard-to-treat, resistant hypertension have an even higher risk of stroke, kidney disease and heart failure.
“We were fortunate to participate in the pivotal trial of this system, which gave us an early understanding of the device. The safety of this outpatient procedure in our experience, and as demonstrated in the trial, is exciting as it opens up a new avenue of treatment for appropriately selected patients with hypertension,” said Amar Krishnaswamy, M.D., Section Head, Interventional Cardiology at Cleveland Clinic.
“As physicians, we strive to provide the most advanced and evidence-based treatment for hypertension patients. Renal denervation is another effective tool that we are excited to be able to offer to help patients with difficult to control hypertension. Our expertise in the diagnosis and treatment of hypertension allows us to select the patients that will most benefit from this new technology,” said Luke Laffin, M.D., Co-Director, Center for Blood Pressure Disorders.
“Renal denervation can be an effective adjunctive therapy for blood pressure control in selected patients, and we are now able to offer this option as an advancement to currently available conventional therapies,” said George Thomas, M.D., Director, Center for Blood Pressure Disorders. “Our team of nephrologists and cardiologists in the Center for Blood Pressure Disorders will work collaboratively to identify patients most likely to benefit from this procedure to manage hypertension and improve outcomes.”
“We know that only a third of people with high blood pressure in the United States have it under control, and it’s great to have a new option to offer patients, when lifestyle modifications and medicine are not working,” said Dr. Aravinda Nanjundappa, interventional cardiologist at Cleveland Clinic, who also performed the first procedure at Cleveland Clinic.