St Jude Medical reports positive 12-month data from EnligHTN III trial

15 September 2014 (Last Updated September 15th, 2014 18:30)

St Jude Medical has reported positive 12-month outcome data from the EnligHTN III study, which demonstrated continuation of safe, rapid and effective treatment with the next-generation EnligHTN Renal Denervation System for patients with drug-resistant, uncontrolled hypertension.

EnligHTN system

St Jude Medical has reported positive 12-month outcome data from the EnligHTN III study, which demonstrated continuation of safe, rapid and effective treatment with the next-generation EnligHTN Renal Denervation System for patients with drug-resistant, uncontrolled hypertension.

Renal denervation is a specialised ablation procedure that reduces blood pressure for patients with hypertension, or high blood pressure, that is resistant to medical therapy.

The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions along the renal nerves, a network of nerves in the walls of the renal arteries said to help control blood pressure.

The intentional disruption of the nerve supply has been found to help reduce systolic and diastolic blood pressure.

The non-occlusive basket design of the system catheter has multiple electrodes, which help physicians deliver a predictable treatment pattern, as well as allow for continuous blood flow to the kidney throughout the procedure.

"This data continue to demonstrate that the multi-electrode system from St Jude Medical provides a safe and effective alternative for patients with drug-resistant and uncontrolled hypertension."

In 2013, the next-generation EnligHTN system secured CE Mark approval and delivered simultaneous ablations via a multi-electrode catheter, reducing total ablation time by more than 80% compared with the first generation system, from about 24 minutes to four minutes.

Principal investigator of the EnligHTN III study and Professor at St Andrew's Hospital Stephen Worthley said: "The 12-month data for EnligHTN III continues to show the benefits of the EnligHTN Renal Denervation System and merits for its potential to change the way hypertension is treated.

"This data continue to demonstrate that the multi-electrode system from St Jude Medical provides a safe and effective alternative for patients with drug-resistant and uncontrolled hypertension."

The international, non-randomised EnligHTN III clinical trial followed device performance and evaluated outcomes at six centres through twelve months of follow-up for 37 eligible patients.

The EnligHTN III trial expands upon the research conducted in the EnligHTN I trial of the first-generation EnligHTN system, which showed that patients with drug-resistant hypertension had a safe drop in blood pressure.


Image: EnligHTN Renal Denervation System illustration. Photo: courtesy of St Jude Medical/ Business Wire.