St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced that interim data demonstrated the company's EnligHTN™
renal denervation system is safe and effective for the treatment of
resistant hypertension. Data released during the ESC (European Society
of Cardiology) Congress 2012 for the EnligHTN I (ARSENAL) trial
demonstrated that on average patients with resistant hypertension
experienced a rapid systolic blood pressure reduction of 28 mmHg points
after 30 days that remained stable with a reduction of 27 mmHg points
three months after treatment.
denervation is a specialized ablation procedure that has been
clinically proven to reduce blood pressure in patients with hypertension
that is resistant to medical therapy. A typical normal blood pressure is
below 120 systolic (the first number) and 80 diastolic (the second
number), and is expressed as 120/80 mmHg. Hypertension, or high blood
pressure, is a blood pressure greater than 140/90 mmHg.
Patients that enrolled in the EnligHTN I trial had an average baseline
blood pressure of 176/96 mmHg. Their blood pressure remained resistant
despite being on three antihypertensive medications, including a
diuretic. Patients who underwent a renal denervation procedure using the
EnligHTN technology demonstrated a rapid 22- mmHg point drop in systolic
blood pressure just prior to their discharge from the hospital. A
further 6-point drop in systolic blood pressure was demonstrated at the
30 day milestone and was sustained at three months.
The total 28- mmHg point reduction of systolic blood pressure after 30
days is double the reduction than that of competitive technology in the
same time frame. This rapid reduction is important because it provides
earlier improvements in patients who have been resistant to other
treatments. Three month results demonstrated the technology remained
safe and effective with a blood pressure reduction that remained
superior to that of competitive technology.