US-based medical technology developer St Jude Medical has enrolled the first patient in a clinical 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.
Using the minimally invasive ablation device, the system delivers radiofrequency energy to create a predictable pattern of four evenly-spaced ablations along the renal sympathetic nerves that help control blood pressure.
The non-randomised, 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 a rapid and sustained drop in blood pressure in patients with drug-resistant hypertension.
The EnligHTN I trial 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 EnligHTN II study, which will enrol 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.
Klinikum Coburg cardiologist Dr Johannes Brachmann said; "Expanding this research to patients with less severe forms of hypertension is important as this minimally invasive approach allows for a shorter procedure time and a potentially faster recovery time, which may benefit more patients with uncontrolled hypertension."
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."
Image: EnligHTN renal denervation system delivers radiofrequency energy to create lesions along the renal sympathetic nerves that help control blood pressure, Photo: Courtesy of St. Jude Medical, Inc.