18-month Average 24 mmHg BP Reduction Reported with St.Jude EnligHTN™ Renal Denervation System

TCT2013 has seen St. Jude Medical, Inc. announce 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 symposium indicates that patients with drug-resistant hypertension treated with the EnligHTN™ Multi-Electrode Renal Denervation System averaged a 24 mmHg reduction in systolic blood pressure as measured in an office setting.

Background

Renal denervation involves the thermal ablation of sympathetic nerves that lie around the renal arteries. This action leads to an immediate and sustained reduction in blood pressure, even in patients with drug-resistant hypertension. Now all the companies with renal denervation systems are clamouring for a piece of the pie, in what is looking like a race to deliver the best results. As such, it’s unsurprising to see clinical data being presented at TCT2013, the focal point for clinicians who specialize in transcatheter techniques.

St.Jude Medical is conducting multiple renal denervation studies to add to the body of evidence supporting the potential of the therapy. A prospective, multi-center 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 / 96 mmHg 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.

Eighteen-Month Data Findings, presented at TCT2013 include:

Average systolic blood pressure reduction of 24 mmHg points

No clinically significant changes in kidney function (longer-term support for safety claims)

77 percent of patients responded to the therapy (blood pressure reduction of at least 10 mmHg when measured during an office visit as compared to baseline).

Previous results from the EnligHTN I trial indicate an average reduction of 26 mmHg at six-months, 27 mmHg at one year and 24 mmHg at 18-months.

Investigator comments

“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 professor Stephen Worthley, from St. Andrew’s Hospital in Adelaide, Australia, a primary investigator in the EnligHTN I trial, who delivered 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.”

Company comments

“St. Jude Medical has invested in a robust clinical program 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 systems are not yet approved for use in the U.S.

Full release here.

Source: St.Jude Medical, Inc., Business Wire