St. Jude Medical's EnligHTN Renal Denervation System Supported by 18-Month Data

October 28, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced new results from the EnligHTN I study that confirm safe, rapid, and sustained reduction in blood pressure measurements at 18 months after treatment with the company's EnligHTN multielectrode renal denervation system. Professor Stephen Worthley, MD, from St. Andrew's Hospital in Adelaide, Australia, a primary investigator in the EnligHTN I trial, presented the findings at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

As summarized by St. Jude Medical, the 18-month data indicate that patients with drug-resistant hypertension treated with the EnligHTN system averaged a 24-mm Hg reduction in systolic blood pressure as measured in an office setting. Renal denervation resulted in no clinically significant changes in kidney function, which supported the longer-term safety profile of the treatment. At 18 months, 77% of patients responded to the therapy, which is defined as a blood pressure reduction of at least 10 mm Hg when measured during an office visit as compared to baseline.

According to the company, the prospective, multicenter EnligHTN I feasibility study treated 46 patients in Australia and Europe whose high blood pressure was considered drug resistant despite taking three or more antihypertensive medications, including a diuretic. Patients enrolled in the study had an average blood pressure of 176/96 mm Hg and on average were taking 4.7 medications to control their hypertension. Patients in the study will continue to be followed for 2 years after their procedure.

Previous results from the EnligHTN I trial indicate an average reduction of 26 mm Hg at 6 months, 27 mm Hg at 1 year, and 24 mm Hg at 18 months, noted the company.

In the company's press release, Prof. Worthley commented, “Convincing clinical evidence continues to emerge that supports the benefits of renal denervation in improving systolic blood pressure for patients with drug-resistant hypertension. The 18-month results of the EnligHTN I study point to an overall reduction in hypertension, which is important, as even modest improvements can have significant health benefits for patients who live with this life-threatening condition. This also supports that the early reduction in blood pressure remains sustained out to 18 months, confirming the durability of this procedure using the EnligHTN catheter.”

In May 2012, the first-generation EnligHTN multielectrode renal denervation system received European CE Mark approval and was launched in several markets. The company also announced CE Mark approval of the next-generation EnligHTN system in August 2013.

In the United States, the EnligHTN systems are not yet approved for use. In June 2013, St. Jude Medical announced US Food and Drug Administration approval of EnligHTN IV clinical trial to evaluate the use of the EnligHTN system to treat 590 patients at up to 80 sites across the United States and Canada with drug-resistant high blood pressure. The EnligHTN IV trial is now enrolling patients in the United States.