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

May 22, 2013—Boston Scientific Corporation (Natick, MA) announced that interim data from the REDUCE-HTN clinical program were presented at EuroPCR 2013 in Paris by Joachim Schofer, MD, of the Hamburg University Cardiovascular Center in Hamburg, Germany.

According to Boston Scientific, the data demonstrated a significant and sustained reduction in blood pressure for the first patients treated with the Vessix renal denervation system. The data are composed of the first 41 patients enrolled in the REDUCE-HTN clinical program. Principal Investigator Prof. Horst Sievert, MD, leads the REDUCE-HTN clinical program. Prof Sievert is Director of the CardioVascular Center Frankfurt at Sankt Katharinen Hospital in Frankfurt, Germany.

In the company's press release, Prof. Sievert commented, “Tens of thousands of patients worldwide have blood pressure that is high and uncontrolled, putting them at significantly increased risk for a variety of cardiovascular diseases, including heart attack, stroke, and kidney failure. The interim data from REDUCE-HTN demonstrate that renal denervation with the Vessix system offers a significant and sustained blood pressure reduction in patients with uncontrolled hypertension. The familiar over-the-wire balloon platform of the Vessix system, the short procedure time, and precise bipolar approach offer a significant step forward in the treatment of this challenging condition.”

The REDUCE-HTN clinical program is evaluating the ability of the Vessix system to reduce blood pressure at 6 months as 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.

As summarized by Boston Scientific, interim data on all 41 patients who underwent successful bilateral renal denervation treatment include the following findings. At the primary endpoint of 6 months, patients experienced a significant 27.6-mm Hg reduction in systolic blood pressure (P < .0001). There were no device-related adverse events or procedural renal artery complications reported. Long-term efficacy was demonstrated, with a sustained 28.4-mm Hg reduction in systolic blood pressure in the subset of patients for whom 12-month data were available. The device demonstrated success in treating various anatomies, including accessory renal arteries, and demonstrated short renal denervation procedural time.

The Vessix system has received CE Mark approval in Europe, where it is marketed as the Vessix V2 renal denervation system. Additionally, the device has received regulatory approval from the Therapeutic Goods Authority of Australia and is available for sale in Australia, New Zealand, the Middle East, and select markets in Asia. The Vessix system is not approved for use or sale in the United States, advised Boston Scientific.

The Vessix renal denervation system was developed by Vessix Vascular, Inc. (Laguna Hills, CA), which was acquired by Boston Scientific in a transaction that was first announced in November 2012.