Medical equipment manufacturer Boston Scientific has enrolled the first patient in the REDUCE-HTN: REINFORCE study, which has been designed to evaluate effectiveness of the Vessix Renal Denervation system.
The study is a randomized, sham-controlled and multicenter study that has been designed to isolate and demonstrate the system’s effects by minimizing variability and factors that may have affected results in a competitive technology trial last year.
New York-based SUNY Downstate College of Medicine medicine professor Michael Weber said: "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.
In December 2014, the company received an investigational device exemption (IDE) approval for the study from the Food & Drug Administration and the first patient was enrolled at Cardiology P.C. at Princeton Baptist Medical Center in Birmingham of Alabama by site principal investigator Farrell Mendelsohn.
The study will enroll up to 100 patients and the primary efficacy assessment is the mean reduction in average 24-hour ambulatory systolic blood pressure (ASBP) at eight weeks post randomization. Results are expected to be released in the first half of this year.
The Vessix System is a differentiated and advanced renal denervation system that uses a multi-electrode bipolar catheter designed to reduce procedural variability.
The system features a 30-second treatment time and an over-the-wire, balloon-based approach, which is followed by most cardiac and vascular specialists.
It received CE mark and Australian Government, Therapeutic Goods Administration (TGA) approval and is marketed in Europe, the Middle East, Australia, New Zealand and select markets in Asia. The system is an investigational device in the US, which is not available for sale.
Image: Boston Scientific has enrolled first patient in the study, designed to evaluate the performance of Vessix Renal Denervation System. Photo: courtesy of Boston Scientific Corporation.