News | May 04, 2015

Boston Scientific Enrolls First Patient In New Study of Vessix Renal Denervation System

Program will evaluate mean reduction in average 24-hour ambulatory systolic blood pressure, minimizing variability

Vessix Renal Denervation System, REDUCE-HTN: REINFORCE, high blood pressure

Vessix System image courtesy of Boston Scientific Corp.

May 4, 2015 — Boston Scientific Corp. is taking a new approach to evaluate the performance of the Vessix Renal Denervation System, initiating a study to isolate the effects of the therapy in patients with high blood pressure.

The first patient in the REDUCE-HTN: REINFORCE study was enrolled this week at Cardiology P.C. at Princeton Baptist Medical Center in Birmingham, Alabama, 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 U.S. Food & Drug Administration (FDA) in December.

REDUCE-HTN: REINFORCE is a randomized, sham-controlled, multicenter 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. 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.

"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," said Martin Leon, M.D., co-principal investigator and director, Center for Interventional Vascular Therapy at Columbia University Medical Center / New York-Presbyterian Hospital, New York City.

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.

"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," said Michael Weber, M.D., co-principal investigator and professor of medicine, SUNY Downstate College of Medicine, Brooklyn, NY. "We need to find clarity, and we believe this innovative study design will enable us to do so."

The 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. The Vessix System has both CE Mark and Australian Government, Therapeutic Goods Administration (TGA) approval and is available for sale in Europe, the Middle East, Australia, New Zealand and select markets in Asia. The Vessix System is an investigational device and not available for sale in the United States.

For more information:

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init