US-based medical technology developer St Jude Medical has announced a study evaluating whether its multi-electrode renal denervation technology can provide additional benefits beyond a reduction in blood pressure.
Featuring a non-occlusive basket design, the CE-marked EnligHTN renal denervation system is a minimally invasive device that delivers radiofrequency energy to create a predictable pattern of four evenly-spaced ablations along the renal sympathetic nerves that help control blood pressure.
The international, multi-centre, randomised, controlled trial, EnligHTNment, will examine the long-term effects of renal denervation in patients with uncontrolled hypertension to check whether it can also reduce the risk of major cardiovascular events such as heart attack, stroke and death.
Zurich University Hospital cardiology and cardiovascular centre chairman and trial principal investigator Professor Thomas Luscher said initial study results have demonstrated that the EnligHTN system is safe and effective in rapidly lowering blood pressure.
"If these results extend into the prevention of major cardiac events, there is the potential to dramatically change how we treat these patients," Luscher said.
The company is also currently conducting two renal denervation studies including EnligHTN I, which showed a rapid and sustained drop in blood pressure in patients with drug-resistant hypertension.
The study also showed that after thirty days of treatment, systolic blood pressure was reduced by an average of 28mmHg and remained stable with 26mmHg at six months, an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20mmHg, according to the company.
The other study is EnligHTN II, which will enrol 500 patients with uncontrolled hypertension to evaluate the mean reduction in systolic blood pressure at six months in patients with post-renal denervation, and within sub-groups with varying degrees of kidney functionality.
Image: The EnligHTN renal denervation system delivers radiofrequency energy to create lesions along the renalsympathetic nerves that help control blood pressure. Photo: Courtesy of St Jude Medical, Inc.