Boston Scientific has begun enrollment of the REDUCE-HTN: REINFORCE study, which will evaluate the efficacy and safety of renal denervation in patients with hypertension, according to a press release.

The randomized, sham-controlled, multicenter study will assess the Vessix Renal Denervation System in 100 patients.

The system incorporates a multielectrode bipolar catheter intended to reduce procedural variability. The device has an over-the-wire, balloon-based approach and a treatment time of 30 seconds, according to the release.

The primary endpoint is mean reduction in 24-hour ambulatory systolic BP at 8 weeks following randomization. Prior to enrollment, all patients will have a 4-week washout period during which all antihypertensive therapies will be discontinued. The goal of the study design is to reduce the influence of factors that may have influenced the results of a competitive technology trial conducted last year, according to the release.

Michael Weber

"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," co-principal investigator Michael Weber, MD, professor of medicine at SUNY Downstate College of Medicine in Brooklyn, New York, and Cardiology TodayEditorial Board member, said in the release. "We need to find clarity, and we believe this innovative study design will enable us to do so."

The company anticipates initial results during the first half of 2016. The Vessix system is an investigational device in the U.S., but has received a CE Mark and Australian TGA approval and is available in Australia, Europe, the Middle East, New Zealand and some markets in Asia, according to the release.

Disclosure: Weber reports consulting for Boston Scientific.

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