St. Jude Medical Begins Enrollment in EnligHTN II Renal Denervation Study

January 30, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced enrollment of the first patient in the postmarket EnligHTN II trial that will further evaluate the safety and efficacy of the company's EnligHTN renal denervation system in patients with uncontrolled hypertension.

According to the company, the EnligHTN II (International Long-term Follow-up Study of Patients With Uncontrolled Hypertension) trial, a nonrandomized, single-arm study, expands upon the research conducted in the EnligHTN I trial, which demonstrated that patients with drug-resistant hypertension treated with the St. Jude Medical EnligHTN system had a rapid and sustained drop in blood pressure. 

The EnligHTN renal denervation system earned European CE Mark approval in 2012 and was launched in several markets. It is not yet approved for use in the United States.

As summarized in St. Jude Medical's press release, 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, an important finding because the risk of cardiovascular death drops by half with every systolic decrease of 20 mm Hg.

Johannes Brachmann, MD, of Klinikum Coburg in Coburg, Germany, commented on the findings in the announcement. He stated, “There is convincing evidence from studies like the EnligHTN I trial linking renal denervation to improved blood pressure in patients who have drug-resistant hypertension. Expanding this research to patients with less severe forms of hypertension is important, as this minimally invasive approach allows for a shorter procedure time and a potentially faster recovery time, which may benefit more patients with uncontrolled hypertension.”

St. Jude Medical stated that the majority of renal denervation studies to date have only tested the safety and efficacy of this technology in patients with drug-resistant hypertension. The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at 6 months across all enrolled patients after renal denervation and within subgroups with varying degrees of kidney functionality. The study will be conducted at 40 sites in Europe and Australia and will enroll approximately 500 patients with uncontrolled hypertension.

St. Jude Medical advised that the EnligHTN system is a multielectrode ablation technology that features a nonocclusive basket design that delivers a predictable pattern of four evenly spaced ablations with each catheter placement. This allows for continuous blood flow to the kidney during the procedure. Compared to single-electrode ablation systems, the multi-electrode EnligHTN system has the potential to improve consistency and save time, which may result in improved workflow and cost efficiencies. The renal denervation technology includes a guiding catheter, ablation catheter, and ablation generator. The generator uses the company's temperature-controlled algorithm to produce effective lesions. Additionally, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic exposure.