St. Jude Medical initiates EnligHTNment study of renal denervation St. Jude Medical announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood pressure. The EnligHTNment trial is the first large-scale study that will examine the long-term effects of renal denervation in patients who have uncontrolled hypertension to see if renal denervation also reduces the risk of major cardiovascular events such as heart attack, stroke and death. St. Jude Medical is currently conducting two additional renal denervation studies called EnligHTN I and EnligHTN II that are evaluating the EnligHTN system for hypertension. Results to-date from the EnligHTN I trial demonstrated that patients with drug-resistant hypertension treated with the St. Jude Medical EnligHTN system had a rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was rapidly reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment. This is an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20 mmHg. The EnligHTN II trial is being conducted at 40 sites in Europe and Australia and will enroll approximately 500 patients with uncontrolled hypertension. The study began enrollment in January 2013 to evaluate the reduction in systolic blood pressure at six months across all enrolled patients after having renal denervation, and within sub-groups with varying degrees of kidney functionality.
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