St. Jude Medical, Inc. announced that preliminary data demonstrated the company’s EnligHTN™ renal denervation system was safe and effective for the treatment of resistant hypertension. The study dem-onstrated that on average patients with resistant hypertension experience a systolic blood pressure re-duction of 28 points after 30 days.
Renal 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 pres-sure 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 trial had an average of 176 / 96 mmHg baseline blood pressure despite be-ing 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 percent of 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 multicenter study. To be considered for enrollment, 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.
Hypertension is a root cause of various life-threatening health problems, including heart disease, stroke, and kidney failure. It impacts more than 1 billion people globally, many of whom do not respond to conventional treatment with medication.