EnligHTN III Evaluates St. Jude Medical's Renal Denervation System

May 22, 2014—St. Jude Medical, Inc. announced that preliminary results from the EnligHTN III study results were presented during a late-breaking clinical trial session at the EuroPCR 2014 congress being held May 20–23 in Paris, France. The study found that the company’s second-generation EnligHTN renal denervation system provided safe and effective therapy for patients with drug-resistant, uncontrolled hypertension 6 months postprocedure.

The EnligHTN III study is an international, nonrandomized clinical trial that followed device performance and assessed outcomes through 6 months of follow-up for 39 eligible patients. Preliminary results confirmed safe, rapid, and sustained reduction in blood pressure measurements for patients with drug-resistant hypertension (high blood pressure that could not be controlled through medication).

The principal investigator of the EnligHTN III study is Prof. Stephen Worthley, MD, of St. Andrew's Hospital in Adelaide, Australia. Prof. Worthley commented in the company’s press release, “This 6-month data from EnligHTN III provides further evidence of the benefits associated with this next-generation renal denervation system. This study demonstrates that the next-generation EnligHTN renal denervation system delivers safe and effective treatment that is aligned with the outcomes of the first-generation system, and ultimately saves time in the procedure room.”

According to the company, the 6-month EnligHTN III data showed an average systolic blood pressure reduction of 25 mm Hg. Additionally, 81% of patients responded to the therapy, which is defined as a blood pressure reduction of at least 10 mm Hg when measured during an office visit. There were no serious device- or procedure-related adverse events reported.

The EnligHTN III study expands upon the research conducted in the EnligHTN I trial of the first-generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe drop in blood pressure.

New data from the EnligHTN I trial, presented at EuroPCR 2014, confirmed that the fast, early reduction in blood pressure remains sustained at 24 months, further demonstrating the long-term benefits of this procedure when using the EnligHTN technology. In this study, 77% of patients were responders at 24 months, with a blood pressure reduction of at least 10 mm Hg. There were 46 patients treated with the EnligHTN system in the EnligHTN I multicenter study. To be considered for enrollment, patients were required to have a systolic blood pressure above 160 mm Hg (150 mm Hg for patients with type II diabetes) and take at least three antihypertensive medications, including a diuretic.

Also presented at EuroPCR were 1-month findings from the postmarket EnligHTN II clinical trial. Preliminary results demonstrated a reduction in systolic blood pressure across subgroups with varying degrees of hypertension and kidney functionality and found an early 14 mm Hg reduction in blood pressure in patients with a systolic blood pressure above 160 mm Hg. Blood pressure reduction for patients with a systolic blood pressure above 160 mm Hg was in line with previous real-world postmarket studies. While still reporting a reduction, patients with poor kidney functionality and a baseline blood pressure lower than 160 mm Hg did not have as large of a reduction of blood pressure at 1 month.

The EnligHTN II trial is being conducted at up to 40 sites in Europe and Australia and will enroll up to 500 patients with uncontrolled hypertension. The data presented during EuroPCR was from 18 centers and 100 patients.

Collectively, the EnligHTN trials are approaching 300 treated patients with ongoing enrollments in the EnligHTN II trial and observational registries across Europe and Australia, noted St. Jude Medical.