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St. Jude Medical, Inc.
STJ, a global medical device company, today
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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