News | April 30, 2013

Boston Scientific Begins Clinical Trial To Evaluate New Pacing System in MRI Environment

Designed to confirm safety and effectiveness of the system in the MRI environment

April 30, 2013 — The first patient in the United States has been implanted with the Boston Scientific Corporation ImageReady MR Conditional pacing system in the SAMURAI clinical trial. The study is designed to confirm the safety and effectiveness of the system in the magnetic resonance imaging (MRI) environment. While MRI images can help clinicians make informed decisions about treatment and care, most pacemakers are not compatible with MRI technology, and therefore patients may not have access to the sophisticated scanning capabilities of the diagnostic system.

The ImageReady pacing system is comprised of the Boston Scientific Ingenio MRI pacemaker family and the new Ingevity MRI pacing leads. The technology is aimed at reducing MRI interference with device performance. In addition, the Ingevity pacing lead platform is designed to provide key enhancements in handling and fixation compared to standard leads, and it is specifically engineered to function in the MRI environment.

"Physicians are very limited in device options and therapies labeled for use in the MRI setting," said Ronald Berger, M.D., Ph.D., professor of medicine, Johns Hopkins Medical Institutions. "The availability of a pacing system specifically designed to allow patients with pacemakers to undergo a broad set of MRI scanning conditions will advance the quality of patient care. The Ingenio MRI pacemaker family also offers pacing technologies not previously available in devices designed for the MRI environment."

The ImageReady pacing system offers Boston Scientific technologies, including RightRate rate adaptive pacing with the Minute Ventilation sensor, to restore chronotropic competence; Rythmiq, which is designed to minimize unnecessary right ventricular pacing without clinically significant pauses; and Latitude NXT, which is geared towards minimizing clinic and patient burden with wireless remote follow-up.

The SAMURAI trial is a prospective, open-label, two-group randomized, multi-center, global clinical study designed to support U.S. Food and Drug Administration (FDA) regulatory approval. The trial is expected to enroll approximately 363 patients at 45 centers in seven countries.

For more information: www.bostonscientific.com

Related Content

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...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init