Boston Scientific initiates REDUCE-HTN: REINFORCE study of Vessix V2 renal denervation system for hypertension.

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

REDUCE-HTN: REINFORCE is a randomized, sham-controlled, multicenter study designed to isolate and demonstrate the effects of the Vessix V2 Renal Denervation System from Boston Scientific, 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 four-week washout period prior to enrollment in which they will stop taking all hypertension medications. The REDUCE-HTN: REINFORCE study will enroll 100 patients. The primary efficacy assessment is the mean reduction in average 24-hour ambulatory systolic blood pressure (ASBP) at eight weeks post randomization. First results may be obtained in the first half of 2016.

Comment:Renal denervation looked promising as a solution to the treatment of resistant hypertension with devices from Medtronic ( Symplicity HTN 3), St. Jude (EnligHTN IV) and Boston Scientific (Vessix) and other manufacturers. However the failure of the Symplicity device to lower blood pressure created a pause in development.The tendency now is for manufacturers, such as St.Jude and Medtronic (with a new Symplicity/Spyral device) to focus on less severe forms of hypertension.