St Jude Medical has enrolled the first patient in EnligHTN II trial of its multi-electrode renal denervation technology for treating patients with drug-resistant hypertension.
The CE-marked EnligHTN renal denervation system, which features a non-occlusive basket design, includes a guiding catheter, ablation catheter and ablation generator.
The system uses minimally invasive ablation device for delivering radiofrequency energy to create a predictable pattern of four evenly-spaced ablations along the renal sympathetic nerves, that help control blood pressure.
The trial, IntErnational non-randomized, single-arm, long-term follow-up study of patients with uncontrolled HyperTensioN (EnligHTN II), expands upon the research conducted in the company’s EnligHTN I trial, which showed rapid and sustained drop in blood pressure in patients with drug-resistant hypertension.
EnligHTN I trial also showed that after thirty days of treatment, systolic blood pressure was reduced by an average of 28 mmHg and remained stable with 26 mmHg at six months after treatment, an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20 mmHg, claims the company.
The EnligHTN II study, which will enroll 500 patients, aims 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.
St Jude Medical cardiovascular and ablation technologies division president Frank Callaghan said, "Through the course of the EnligHTN II study, we expect to gain additional insights into the benefits and sustainability of blood pressure reductions achieved through use of the EnligHTN Renal Denervation System in an expanded patient population."