St. Jude Medical, a medical device firm, has announced that its EnligHTN Multi-Electrode Renal Denervation System offers a safe, rapid and sustained reduction in measurements of blood pressure after a year.
The company presented the new one-year study data on the EnligHTN I trial at EuroPCR 2013 in Paris.
Renal denervation system is a catheter-based ablation procedure that treats drug-resistant hypertension.
The observation in the clinical trial was that the patients who were treated with EnligHTN Renal Denervation System experienced an average systolic blood pressure reduction of 27 mmHg points when measured in an office setting.
The key findings of the study are – an average systolic blood pressure reduction of 27mmHg points was reported; 80% of patients responded to the therapy; the longer-term safety profile for renal denervation was supported by showing no significant changes in kidney function.
Royal Adelaide Hospital Australia professor and EnligHTN I trial primary investigator Stephen Worthley said that hypertension can be difficult to treat and the need for additional options is great considering the growing number of patients with high blood pressure who are at risk for heart attack, stroke and death.
"The results of the EnligHTN I study confirm that the early significant reduction in blood pressure is sustained through 12 months, but as important are the favorable renal effects as evidenced by an improvement in some kidney markers," Worthley added.
The EnligHTN I trial treated 46 patients whose blood pressure was considered drug resistant despite taking three or more antihypertensive medications including a diuretic.
St. Jude Medical Cardiovascular and Ablation Technologies Division president Frank Callaghan said that the one year results of the EnligHTN I trial are important as they further substantiate that blood pressure can safely and effectively be reduced with the EnligHTN Renal Denervation System in this challenging patient population.
"We are pleased that the study continues to report a sustained reduction in hypertension, potentially providing a long-term benefit for patients whose lives are impacted by this difficult-to-treat condition," Callaghan added.
Renal denervation represents an important area of research in the management of hypertension for the estimated one billion people globally who live with this life-threatening condition.
St. Jude Medical is currently conducting renal denervation studies to add to the body of evidence supporting the potential of this new therapy. These include EnligHTN I trial, EnligHTN II trial, EnligHTN III trial, EnligHTN IV trial and EnligHTNment trial.