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Landmark trial initiated on renal denervation system
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St. Jude Medical has announced today plans for a landmark trial that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high BP.
The international, multicenter, randomized controlled trial, called EnligHTNment, will test the long-term effects of the company’s renal denervation system (EnligHTN) in patients with uncontrolled hypertension. According to a press release, EnligHTNment will be the first large-scale trial to examine whether renal denervation can provide health benefits beyond lowering BP, including whether it can also reduce the risk of major CV events, including MI, stroke and death.
“To date, the renal denervation studies that have been conducted only looked at reducing BP in patients with uncontrolled or resistant hypertension,” Michael Böhm, MD, PhD, director and chief of internal medicine and cardiology at the University of Saarland in Homburg/Saar, Germany and principal investigator for EnligHTNment, said in the release. “What we need to know is if this minimally invasive approach for treating hypertension also correlates to a reduction in major cardiac events such as heart attack, stroke and death, which are the primary risks for patients whose BP is not well controlled.”
St. Jude Medical is currently also conducting the EnligHTN I and EnligHTN II trials, which are evaluating the EnligHTN system in patients with drug-resistant (EnligHTN I) or uncontrolled (EnligHTN II) hypertension.
The EnligHTN Renal Denervation System earned a CE mark in 2012 and was launched in several markets, but is not yet approved for use in the United States.