St Jude Medical has announced new results from the EnligHTN I study, confirming safe, rapid and sustained reduction in blood pressure measurements a year and a half post-procedure.
Data presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium (San Francisco, USA, 27 October–1 November) indicates that patients with drug-resistant hypertension treated with the EnligHTN multi-electrode renal denervation system averaged a 24mmHg reduction in systolic blood pressure as measured in an office setting.
“Convincing clinical evidence continues to emerge that supports the benefits of renal denervation in improving systolic blood pressure for patients with drug-resistant hypertension,” said Stephen Worthley, St Andrew’s Hospital, Adelaide, Australia, a primary investigator in the EnligHTN I trial, who presented the findings at TCT. “The 18-month results of the EnligHTN I study point to an overall reduction in hypertension, which is important as even modest improvements can have significant health benefits for patients who live with this life-threatening condition. This also supports that the early reduction in blood pressure remains sustained out to 18-months, confirming the durability of this procedure using the EnligHTN catheter.”
Eighteen-month data:
- An average systolic blood pressure reduction of 24mmHg points was reported
- The longer-term safety profile for renal denervation was supported by showing no clinically significant changes in kidney function
- At 18-months, 77% of patients responded to the therapy, which is defined as a blood pressure reduction of at least 10mmHg when measured during an office visit as compared to baseline.
A prospective, multi-centre feasibility study, the EnligHTN I trial treated 46 patients in Australia and Europe whose high blood pressure was considered drug resistant despite taking three or more anti-hypertensive medications including a diuretic. Patients enrolled in the study had an average blood pressure of 176/96mmHg and on average were taking 4.7 medications to control their hypertension. Patients in the study will continue to be followed for two years after their procedure.
Previous results from the EnligHTN I trial indicate an average reduction of 26mmHg at six-months, 27mmHg at one year and 24mmHg at 18-months.
“St Jude Medical has invested in a robust clinical programme to build the body of clinical evidence intended to support renal denervation as the standard of care for the treatment of drug-resistant hypertension,” said Frank J Callaghan, president of the St Jude Medical Cardiovascular and Ablation Technologies Division. “These new data from our first renal denervation study demonstrate this therapy is durable and can benefit patients struggling to control their hypertension.”
The EnligHTN system is not approved for use in the USA.
