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Boston Scientific admits first patient in new study to demonstrate the effect of the Vessix Renal Denervation System in patients with hypertension in the US
17 April 2015 - Medical company Boston Scientific (NYSE:BSX) said on Thursday that it plans to evaluate the performance of the Vessix Renal Denervation System to initiate a study with a novel design to isolate the effects of the therapy in patients with high blood pressure.The first patient in the company's REDUCE-HTN: REINFORCE study was enrolled at Cardiology P.C. at Princeton Baptist Medical Center in Birmingham, Ala.According to the company, REDUCE-HTN: REINFORCE is a randomized, sham-controlled, multicentre study 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. The patients will undergo a four-week washout period prior to enrollment in which they will stop taking all hypertension medications. The study will enroll 100 patients.In addition, the company revealed the primary efficacy assessment is the mean reduction in average 24-hour ambulatory systolic blood pressure (ASBP) at eight weeks post randomization, with first results in the first half of 2016.This Vessix System is a differentiated and advanced renal denervation system using a multi-electrode 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, concluded the company.
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