(MarketWatch.com) — Medtronic Inc. announced today the start of SYMPLICITY HTN-3, the company’s U.S. clinical trial of the Symplicity(R) Renal Denervation System(TM) for treatment-resistant hypertension. The first patient in this landmark study was enrolled at the Prairie Heart Institute at St. John’s Hospital in Springfield, Ill.
Treatment resistant hypertension, defined as persistently high blood pressure despite three or more antihypertensive medications of different types, puts approximately 120 million people worldwide at risk of premature death from kidney disease and cardiovascular events such as stroke, heart attack and heart failure.
Renal denervation is a minimally invasive, catheter-based procedure that modulates the output of nerves that line the walls of the arteries leading to the kidneys. The targeted nerves are part of the sympathetic nervous system, which has been found to play a central role in blood pressure regulation.
SYMPLICITY HTN-3 is a randomized controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity Renal Denervation System in patients with treatment-resistant hypertension.
The study will enroll approximately 530 treatment-resistant hypertension patients across 60 U.S. medical centers. All patients and hypertension follow-up assessors will be blinded to the randomization assignments to remove any potential for bias. The primary endpoints of the study are the change in blood pressure from baseline to six months and incidence of major adverse events up to six months following randomization.
More information about SYMPLICITY HTN-3 and renal denervation is available online at www.SymplifyBPtrial.com .
“Renal denervation has the potential to extend the lives of millions of people who suffer from treatment-resistant hypertension,” said Krishna Rocha-Singh, M.D., medical director of the Prairie Vascular Institute and the Prairie Education and Research Cooperative. “Based on the results of prior clinical studies and contemporary clinical practice, this interventional technique could be one of the most significant advances in our approach to addressing this insidious disease to be developed in decades.”
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