Boston Scientific Begins Novel REDUCE-HTN: REINFORCE Study of Vessix Renal Denervation System

April 16, 2015—Boston Scientific Corporation announced the initiation of the REDUCE-HTN: REINFORCE study, which is taking a new approach to evaluate the performance of the Vessix renal denervation system by using a novel design to isolate the effects of the therapy in patients with high blood pressure. The study’s first patient was enrolled by Farrell Mendelsohn, MD, of Cardiology PC at Princeton Baptist Medical Center in Birmingham, Alabama. 

The Vessix system’s multielectrode bipolar catheter is designed to reduce procedural variability. The system uses a 30-second treatment time and an over-the-wire, balloon-based approach, noted the company.

According to Boston Scientific, REDUCE-HTN: REINFORCE is a randomized, sham-controlled, multicenter study that is designed to isolate and demonstrate the effects of the Vessix renal denervation system by minimizing variability and factors that may have affected results in a competitive technology trial last year. Similar to pharmaceutical early-effectiveness studies, patients in the study will undergo a 4-week washout period before enrollment in which they will stop taking all hypertension medications.

The study will enroll 100 patients. The primary efficacy assessment is the mean reduction in average 24-hour ambulatory systolic blood pressure at 8 weeks after randomization. First results may be obtained in the first half of 2016, advised the company. 

The coprincipal investigators of the REDUCE-HTN: REINFORCE study are Martin Leon, MD, and Michael Weber, MD. Dr. Leon is Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York. Dr. Weber is Professor of Medicine at SUNY Downstate College of Medicine in Brooklyn, New York.

In the company’s press release, Dr. Leon commented, “Patients with hypertension need a better therapy, and we believe this study design will help us to understand better the clinical value of renal denervation.” 

Dr. Weber added, “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. We need to find clarity, and we believe this innovative study design will enable us to do so.”

The United States Food & Drug Administration approved an investigational device exemption for the study in December 2014. The Vessix system is an investigational device and is not available for sale in the United States.

The Vessix system has received European CE Mark approval and Australian Therapeutic Goods Administration approval. The device is available for sale in Europe, the Middle East, Australia, New Zealand, and select markets in Asia.