Results from the EnligHTN I trial have shown that the EnligHTN renal denervation system (St Jude Medical) is safe and effective for the treatment of resistant hypertension. Data released during the ESC Congress 2012 demonstrated that on average patients with resistant hypertension experienced a rapid systolic blood pressure reduction of 28 mmHg points after 30 days that remained stable with a reduction of 27 mmHg points three months after treatment.
Patients that enrolled in the EnligHTN I trial had an average baseline blood pressure of 176/96 mmHg. Their blood pressure remained resistant despite being on three antihypertensive medications, including a diuretic. Patients who underwent a renal denervation procedure using the EnligHTN technology demonstrated a rapid 22- mmHg point drop in systolic blood pressure just prior to their discharge from the hospital. A further 6-point drop in systolic blood pressure was demonstrated at the 30 day milestone and was sustained at three months.
“The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure, so it is a tremendous benefit to patients that the EnligHTN renal denervation technology is able to reduce blood pressure very rapidly at one month and sustain that reduction,” said the trial’s primary investigator Costas Tsioufis, professor of Cardiology at University of Athens Hippocration Hospital and professor of Medicine, Georgetown University, Washington DC, USA. “The fact that this rapid and sustained reduction was further confirmed with rigorous ambulatory blood pressure measurements gives me confidence to say that the EnligHTN system delivers a promising therapy for the treatment of resistant hypertension.”
Forty-six patients were treated with the EnligHTN system in the multicentre study. To be considered for enrolment, patients were required to have a systolic blood pressure above 160 mmHg (150 for patients with type 2 diabetes) and take at least three antihypertensive medications concurrently at maximally tolerated doses, including a diuretic.
EnligHTN received CE mark approval in May 2012.