St Jude Medical has announced that the US Food and Drug Administration (FDA) has approved the initiation of the EnligHTN IV Renal Denervation Study, which, according to the company, is the first US trial using the EnligHTN multi-electrode renal denervation system to treat patients with drug-resistant hypertension.
“Sub-optimal blood pressure control is the most common attributable risk for death worldwide,” said William B White, professor and chief of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut Health Center in Farmington, USA, and co-chair of the EnligHTN IV steering committee. “Despite the availability of several effective drugs, approximately 50% of patients have inadequately controlled blood pressure and 8% to 12% are considered resistant to these medications. Renal denervation therapy may be an important advancement for these patients.”
William Gray, interventional cardiologist at Columbia University Medical Center in New York City, USA, and co-chair of the EnligHTN IV steering committee stated, “The EnligHTN renal denervation system has shown tremendous promise in clinical studies outside the USA. We look forward to participating in this important study that has the real potential to change medical practice.”
The EnligHTN IV study, according to the company, is a randomised, single-blind, controlled, multicentre trial to investigate the safety and effectiveness of the EnligHTN renal denervation system in reducing systolic blood pressure when measured in an office setting. The study is expected to enrol approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients are expected to be enrolled at up to 80 sites in the USA and Canada.
The EnligHTN multi-electrode renal denervation system received the CE mark and was launched in several markets, according to a press release. The EnligHTN IV trial is being conducted under an investigational device exemption (IDE) from the FDA.