St. Jude Medical Inc. (STJ: Quote) announced enrollment of the first patient in the EnligHTN II trial. The company said that the 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 or 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, or 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.
Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood throughout the body. A typical normal blood pressure reading is below 120 systolic and 80 diastolic – expressed as 120 / 80 mmHg.
The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at six months across all enrolled patients post renal denervation and within sub-groups with varying degrees of kidney functionality. The study will be conducted at 40 sites in Europe and Australia and will enroll approximately 500 patients with uncontrolled hypertension.
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by RTT Staff Writer
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