One-Year Data Demonstrate Safe, Rapid, and Sustained Blood Pressure Reduction With St. Jude Medical's EnligHTN Renal Denervation Technology

May 23, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced that the company's EnligHTN multielectrode renal denervation system provides a safe, rapid, and sustained reduction in blood pressure measurements after 1 year. The new 1-year study data from the EnligHTN I trial were presented at EuroPCR 2013 in Paris, France.

The patients enrolled in the EnligHTN I trial had an average blood pressure of 176/96 mm Hg. These patients had drug-resistant hypertension, meaning their blood pressure could not be controlled through medication. At 1 year, patients treated with the EnligHTN renal denervation system experienced an average systolic blood pressure reduction of 27 mm Hg when measured in an office setting. Additionally, 80% of patients responded to the therapy (defined as a blood pressure reduction of at least 10 mm Hg when measured during an office visit), and the longer-term safety profile for renal denervation was supported by showing no significant changes in kidney function, the company stated.

A prospective, multicenter feasibility study, the EnligHTN I trial treated 46 patients whose blood pressure was considered drug resistant despite taking three or more antihypertensive medications, including a diuretic. To qualify for the study, patients had a systolic blood pressure ≥ 160 mm Hg (150 mm Hg for patients with type 2 diabetes). Patients in the trial will continue to be followed for a total of 2 years postprocedure.

“Hypertension can be difficult to treat, and the need for additional options is great, considering the growing number of patients with high blood pressure who are at risk for heart attack, stroke and death,” said Prof. Stephen Worthley of the Royal Adelaide Hospital in Australia, in the company's press release. Prof. Worthley is a primary investigator of the EnligHTN I trial. “The results of the EnligHTN I study confirm that the early significant reduction in blood pressure is sustained through 12 months, but as important are the favorable renal effects as evidenced by an improvement in some kidney markers. Renal denervation has tremendous potential for patients with severe hypertension who are not responding to medication.”