St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced preliminary results from the EnligHTN III study, which found the company’s second-generation EnligHTN™ renal denervation system provided safe and effective therapy for patients with drug-resistant, uncontrolled hypertension six months post-procedure. The results were presented during a hot line late-breaking clinical trial session at EuroPCR 2014.
The EnligHTN III study is an international, non-randomized clinical trial that followed device performance and assessed outcomes through six 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, meaning their high blood pressure could not be controlled through medication.
“This six-month data from EnligHTN III provides further evidence of the benefits associated with this next-generation renal denervation system,” said Prof. Stephen Worthley of St. Andrew's Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III study. “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.”
Six-month EnligHTN III data showed:
EnligHTN I and EnligHTN II Data
- An average systolic blood pressure reduction of 25 mmHg points
- 81 percent of patients responded to the therapy, which is defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit
- No serious device- or procedure-related adverse events reported
The EnligHTN III study expands upon the research conducted in the
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 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. 77 percent of patients were responders at 24 months, with a blood pressure reduction of at least 10 mmHg.
Forty-six patients were 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 mmHg (150 mmHg for patients with type II diabetes) and take at least three antihypertensive medications, including a diuretic. Notably, the EnligHTN I study reports the longest term follow-up to date on a multi-electrode ablation catheter.