St Jude Medical has announced that preliminary data demonstrated the company’s EnligHTN renal denervation system was safe and effective for the treatment of resistant hypertension. The study demonstrated that on average patients with resistant hypertension experience a systolic blood pressure reduction of 28 points after 30 days.
Patients that enrolled in the trial had an average of 176 / 96 mmHg baseline blood pressure despite being on multiple medications to help control blood pressure. The results after 30 days demonstrated:
- An average blood pressure of 148 / 87 mmHg, a 28 point reduction in systolic pressure
- A reduction in systolic blood pressure to below 140 mmHg in 41% of patients
“The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is,” said Stephen Worthley, Royal Adelaide Hospital, Australia and primary investigator of the trial. “From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients.”
Results from other clinical trials for competitive technologies studying the safety and efficacy of renal denervation demonstrated that results improve over time. After 30 days, a 14 point reduction in systolic blood pressure was noted in a competitor’s study, but this number improved to a reduction of 27 points of systolic blood pressure after one year. Compared to this competitive technology, the average 30-day results from the EnligHTN renal denervation trial showed double the reduction in blood pressure at 30 days. Further, the renal denervation treatment was successfully delivered with no serious complications related to the procedure or device.
Forty seven patients enrolled in the multicentre study. To be considered for enrolment, patients were required to have a systolic blood pressure above 160 (150 for patients with type 2 diabetes) and take at least three antihypertensive medications concurrently at maximally tolerated doses, including a diuretic.