St. Jude Medical Begins EnligHTN III Study for Next-Generation Renal Denervation System

May 14, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced the commencement of enrollment in the EnligHTN III trial that will evaluate the safety and performance of the company's second-generation EnligHTN renal denervation system in patients with drug-resistant, uncontrolled hypertension.

According to St. Jude Medical's announcement, the international, nonrandomized EnligHTN III clinical trial will enroll up to 50 patients in Australia and New Zealand with drug-resistant hypertension. To qualify for participation in the study, patients must have systolic blood pressure that remains greater than 160 mm Hg as measured during office visits, despite the use of three antihypertensive medications concurrently at the maximum tolerated doses, one of which is a diuretic.

St. Jude Medical noted that the EnligHTN III study expands upon the research conducted in the EnligHTN I trial of the first-generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid, and sustained drop in blood pressure. After 30 days, systolic blood pressure was reduced by an average of 28 mm Hg that remained stable with a reduction of 26 mm Hg points 6 months after treatment.

The company stated that this next-generation system utilizes the multielectrode catheter paired with a new generator. The generator features a high-tech, icon-friendly, touchscreen user interface that provides simultaneous ablations using four electrodes. This advancement reduces total ablation time from approximately 24 minutes to 4 minutes.

Prof. Stephen Worthley of St. Andrew's Hospital in Adelaide, Australia, is a Principal Investigator of the EnligHTN III trial. In the St. Jude Medical press release, Prof. Worthley commented, “Lowering hypertension is important, as the risk of cardiovascular death doubles with every 20-point increase in systolic blood pressure. The ability of the next-generation EnligHTN system to deliver simultaneous ablations and the intuitive touch screen on the generator are advancements that simplified use, markedly reduced procedure times and was well tolerated by our patients."

St. Jude Medical advised that the second-generation EnligHTN system is not approved anywhere in the world. The first-generation EnligHTN system earned European CE Mark approval and was launched in several markets. These systems are not approved for use in the United States.