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St. Jude Medical announced preliminary results Thursday demonstrating that its second-generation EnligHTN renal denervation system provided "safe and effective" therapy for patients with drug-resistant, uncontrolled hypertension six months post-procedure. Chief medical officer Mark D. Carlson said the company "is encouraged by the positive clinical results" from the EnligHTN III trial, which were presented at EuroPCR 2014.
Questions were raised at the start of the year over the use of renal denervation systems following the failure of a study conducted by Medtronic. Boston Scientific subsequently paused the start of a pivotal trial for its Vessix renal denervation system, while Covidien said it would exit the market. However, Carlson noted on Thursday that St. Jude Medical "will continue to invest in renal denervation as a potential long-term growth driver."
Six-month results from the 39-patient EnligHTN III study suggested an average systolic blood pressure reduction of 25 mmHg. Also 81 percent of participants responded to the EnligHTN renal denervation system, defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit. The company said that no serious device- or procedure-related adverse events were reported. Principal investigator Stephen Worthley remarked that the data "provides further evidence of the benefits associated with this next-generation renal denervation system."
The EnligHTN III trial expands upon the EnligHTN I study of the first-generation EnligHTN system, which showed that the 46 patients with drug-resistant hypertension who were treated with St. Jude Medical's device had a safe drop in blood pressure. New data from the EnligHTN I trial, also presented at EuroPCR, confirmed the results at 24 months, with 77 percent of patients having a blood pressure reduction of at least 10 mmHg.
Also presented at EuroPCR were one-month findings from the first 100 patients with uncontrolled hypertension enrolled in the 500-patient EnligHTN II trial. Preliminary data showed a reduction in systolic blood pressure across sub-groups with varying degrees of hypertension and kidney function, and an early 14 mmHg reduction in blood pressure in those with a systolic blood pressure above 160 mmHg. St. Jude Medical noted that blood pressure reduction for patients with a systolic blood pressure above 160 mmHg was in-line with previous real-world, post-market studies. Patients with poor kidney function and blood pressure lower than 160 mmHg did not have as large of a blood pressure reduction.
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