Researchers think that hyperactivity of the sympathetic nervous system, which connects the brain, heart, blood vessels and kidneys -- each of which plays an important role in blood pressure -- contributes to resistant hypertension. The Simplicity renal denervation system seeks to reduce the drive of the sympathetic nervous system by preventing it from sending out erroneous signals to the brain to increase blood pressure.
In the Symplicity system, a catheter is introduced through a very small incision in the groin and is threaded up into the renal arteries that supply blood to the kidneys. Once in place, the catheter sends out radio waves at a preset frequency generated by a proprietary generator, which target the sympathetic nerves without damaging the surrounding blood vessels. The catheter is removed once the radiofrequency waves have been delivered at multiple locations along the artery.
Affecting about 76.4 million people over the age of 20 nationwide, hypertension is a common cardiovascular disorder in which blood-pressure levels are abnormally elevated -- systolic blood pressure of 140 or greater or diastolic blood pressure of 90 or greater -- over a sustained period of time. Hypertension is considered to be treatment-resistant when a patient's blood pressure remains high despite treatment with three or more antihypertensive medications.
The U.S. Food and Drug Administration approved the Symplicity HTN-3 study protocol in July 2011. NewYork-Presbyterian Hospital is currently enrolling patients for the study, which altogether will randomize 530 patients to receive either renal denervation combined with antihypertensive medications or treatment with an
|Contact: Douglas Feingold|
New York- Presbyterian Hospital/Columbia University Medical Center