REDUCE-HTN Data Support Boston Scientific's Vessix Renal Denervation System

October 28, 2013—Boston Scientific Corporation (Natick, MA) announced that new data presented at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California, demonstrated that patients treated with the company's Vessix renal denervation system experienced a significant and sustained reduction in blood pressure. The data from an interim analysis of 139 patients enrolled in the REDUCE-HTN postmarket study affirmed the device's safety profile and effectiveness as treatment for resistant hypertension.

The REDUCE-HTN program's principal investigator Prof. Horst Sievert, MD, commented in the company's press release, “In the REDUCE-HTN study, 85% of patients treated with the Vessix system experienced a clinically meaningful decrease in blood pressure. In my opinion, the large patient cohort and rigorous analysis of the study suggest that renal denervation using bipolar technology will be an important part of the treatment algorithm for a wide variety of patients with resistant hypertension.” Prof. Sievert is Director of the CardioVascular Center Frankfurt at Sankt Katharinen Hospital in Frankfurt, Germany.

According to the company, the REDUCE-HTN postmarket study, which enrolled 146 patients at 23 centers in Europe, Australia, and New Zealand, is evaluating the ability of the Vessix system to reduce blood pressure at 6 months compared to the pretreatment baseline blood pressure. Patients enrolled in the program are required to have a systolic blood pressure of at least 160 mm Hg despite taking three or more antihypertensive medications.

Boston Scientific reported that interim data highlights of the study include:

• A significant 24.6 mm Hg reduction in systolic blood pressure (P < .0001) at 6 months;

• A sustained 29.6 mm Hg reduction in systolic blood pressure in the subset of patients for whom 12-month data are available;

• A clinically meaningful decrease in office systolic blood pressure at both 6 and 12 months in 85% of patients in the trial;

• Success reducing blood pressure in a variety of subgroups, including both men and women, patients with type 2 diabetes, and patients aged of 65 years or older;

• A strong safety profile, with no occurrence of prespecified acute safety events and with eight procedure-related serious adverse events (5.5%) among the 146 patients; and

• Treatment of a wide range of anatomies, including accessory renal arteries.

The Vessix system has both European CE Mark and Australian Therapeutics Good Administration approval and is currently available for sale in Europe, the Middle East, Australia, New Zealand and select markets in Asia. The Vessix system is an investigational device and not available for sale in the United States, advised Boston Scientific.