May 18, 2012 -- St. Jude Medical Inc., a global medical device company, 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.
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 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 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 percent 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 the trial’s Primary Investigator Prof. Stephen Worthley, Royal Adelaide Hospital in Australia. “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 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 accounts for millions of deaths every year, so it is encouraging that just ahead of World Hypertension Day, new data demonstrate that there is a safe and effective solution to help reduce blood pressure in patients where other treatments aren’t working,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “The EnligHTN system is truly a unique technology that we believe has the potential to reduce a root cause of some of the world’s most burdensome cardiovascular diseases and help patients around the world live more healthy lives.”
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.
About the EnligHTN Renal Denervation System
The EnligHTN system is a multi-electrode ablation technology for renal denervation. With its unique basket design, each placement of the ablation catheter administers a reliable and repeatable treatment pattern. Compared to single-electrode ablations systems, the multi-electrode EnligHTN system has the potential to improve consistency, save time as well as result in workflow and cost efficiencies. Additionally, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure.
Using the new EnligHTN system, an ablation catheter delivers radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves – a network of nerves that help control blood pressure; the intentional disruption of the nerve supply has been clinically found to cause systolic blood pressure to decrease.
The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to produce effective lesions.
For more information: www.SJMenligHTN.com