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St. Jude Medical, Inc. (NYSE: STJ) announced enrollment of the first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN™ Renal Denervation System in patients with uncontrolled hypertension. According to the World Health Organization (WHO), one in three adults worldwide has elevated blood pressure – a condition that increases the risk of heart attack, stroke and kidney failure.
The EnligHTN II (IntErnational non-randomized, single-arm, long-term follow-up study of patients with uncontrolled HyperTensioN) trial expands upon the research conducted in the EnligHTN I trial, which 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 reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment, an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20 mmHg.
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