First patient enrolled in Vessix sham-controlled study


Boston Scientific has announced that it is taking a new approach to evaluate the performance of its Vessix renal denervation system—it is initiating a study with a novel design to isolate the effects of the therapy in patients with high blood pressure. The REDUCE-HTN: REINFORCE randomised, sham-controlled, multicentre study is designed to isolate and demonstrate the effects of the Vessix renal denervation system by minimising variability and factors that may have affected results in SYMPLICITY HTN-3.

According to a press release, the first patient in the REDUCE-HTN: REINFORCE study was enrolled this week at Cardiology P.C. at Princeton Baptist Medical Center in Birmingham, USA by Farrell Mendelsohn (site principal investigator) and referred by Michael Wilensky. Boston Scientific has received an investigational device exemption (IDE) for the study from the FDA.

The REDUCE-HTN: REINFORCE study will enrol 100 patients. The primary efficacy assessment is the mean reduction in average 24-hour ambulatory systolic blood pressure at eight weeks post randomisation. First results may be obtained in the first half of 2016.

The press release reports that the Vessix system is a differentiated and advanced renal denervation system using a multielectrode bipolar catheter designed to reduce procedural variability. It features a 30-second treatment time and an over-the-wire, balloon-based approach familiar to most cardiac and vascular specialists.

“Previous results of renal denervation studies have been affected by a focus on patients with the difficult-to-define condition of treatment-resistant hypertension, made even more complex by uncertainties regarding their use of hypertension medications,” says Michael Weber, co-principal investigator and professor of medicine, SUNY Downstate College of Medicine, Brooklyn, NY. “We need to find clarity, and we believe this innovative study design will enable us to do so.”