St Jude Medical is planning to begin EnligHTNment study, designed to evaluate whether patients with hypertension treated with its EnligHTN renal denervation system can provide additional benefits beyond a reduction in blood pressure.
The CE-marked minimally invasive device, which features a non-occlusive basket design, includes multi-electrode renal denervation technology 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-center, randomized, controlled trial will examine the long-term effects of renal denervation in patients with uncontrolled hypertension to check whether renal denervation can also reduce the risk of major cardiovascular events such as heart attack, stroke and death.
Zurich University Hospital cardiology and cardiovascular center chairman and trial’s 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 added.
In addition, the company is 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 and demonstrated that after thirty days of treatment, systolic blood pressure was reduced by an average of 28mmHg and remained stable with 26mmHg at six months.
The reduction of systolic blood pressure is an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20 mmHg, according to the US based company.
Other study includes EnligHTN II, which will enroll 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.