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|Significant Blood Pressure Reduction from St. Jude Medical's EnligHTN Renal Denervation Technology is Safe, Effective and Sustained at Six Months|
Data from multi-electrode renal denervation catheter study presented
today at the annual scientific meeting of the
Renal denervation is a minimally invasive approach for the treatment of patients with drug-resistant hypertension. It is a specialized ablation procedure that targets nerves in the renal arteries leading to the kidneys that has been clinically proven to reduce blood pressure. 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. The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.
Patients enrolled in the EnligHTN I study had an average blood pressure of 176 / 96 mmHg despite being treated with multiple medications to manage this condition. Those treated with the EnligHTN renal denervation system experienced an average rapid systolic blood pressure reduction of 28 mmHg points after 30 days.
At six months:
“Managing blood pressure is a critical factor in maintaining the overall
cardiovascular health of patients with drug-resistant hypertension,”
A prospective, multi-center feasibility study, the EnligHTN I trial treated 46 patients whose blood pressure remained resistant despite being on three antihypertensive medications and a diuretic. To be considered for the study, patients were required to have a systolic blood pressure greater than or equal to 160 mmHg (150 mmHg for patients with type 2 diabetes).
“Renal denervation represents an important area of research in the
management of hypertension for the millions of patients who live with
this life-threatening condition,” said
About Renal Denervation and the EnligHTN System
The EnligHTN system is a multi-electrode ablation technology for renal denervation. 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 and diastolic blood pressure to decrease.
With its unique basket design, each placement of the ablation catheter administers a predictable treatment pattern. The non-occlusive basket design allows for continuous blood flow to the kidney during the procedure. Compared to single-electrode ablation systems, the four-point contact of the multi-electrode EnligHTN system has the potential to improve consistency, save time as well as result in workflow and cost efficiencies.
The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to produce effective lesions. Additionally, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure.
The EnligHTN Renal Denervation System earned European CE Mark approval and launched this year in several markets. It is not approved for use in the U.S.
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