US-based medical device company St Jude Medical has commenced its EnligHTNment clinical study.
The EnligHTNment study will assess whether the EnligHTN Multi-Electrode Renal Denervation System can minimize the risk of major cardiovascular events such as heart attack, stroke, heart failure and cardiovascular death.
University Hospital, Switzerland, cardiology and cardiovascular center chairman and trial’s principal investigator Thomas Lüscher said that the EnligHTNment trial will provide key insight into whether renal denervation therapy can reduce common cardiovascular complications of high blood pressure.
"Learning more about renal denervation’s impact on major cardiovascular diseases will provide critical information on the health effects and potential benefits of the therapy in patients who currently don’t have an adequate treatment option," Lüscher added.
The study’s primary endpoints include major cardiovascular events such as heart attack, stroke, heart failure with hospitalization and cardiovascular death while Secondary endpoints include the reduction of in-office and ambulatory blood pressure and changes in renal function.
Renal denervation therapy in the EnligHTNment study will use the EnligHTN Renal Denervation System.
St. Jude Medical Cardiovascular and Ablation Technologies Division president Frank Callaghan said that the company is pleased to start the landmark EnligHTNment trial to learn more about the long-term effects of uncontrolled hypertension and to see how we can better assist physicians in treating at-risk patients.
"We are committed to being a leader in clinical research and have put in place a team of highly respected thought leaders to run this trial. We look forward to working with the steering committee and study investigators in the coming years," Callaghan added.