News | EP Lab | October 30, 2015

Boston Scientific Announces CE Mark For MRI-compatible ICD, CRT-D Labeling

Updated labeling allows backwards-compatibility for MRI scans, improving device longevity

Boston Scientific, CE Mark, MRI conditional labeling, CRT-Ds, ICDs

X4 CRT-D system image courtesy of Boston Scientific

October 30, 2015 — Boston Scientific Corp. has received CE Mark on magnetic resonance imaging (MRI) conditional labeling for the current family of EL (Extended Longevity) and Mini implantable cardioverter defibrillator (ICD) and the X4 cardiac resynchronization therapy defibrillator (CRT-D) systems. This revised labeling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated.

Patients with implantable cardiac devices have a wide variety of diagnostic imaging available to them, including X-rays and computed tomography (CT) scans, but Boston Scientific systems had not been evaluated as MRI conditional. This new system labeling, referred to as ImageReady MR Conditional devices, stipulates the conditions under which the systems are considered safe for use in a MRI setting.

"While the broader imaging compatibility will be important for some patients, I still expect device longevity and the ability to mitigate risk of complications to be the most critical factors in choosing the best system for each patient," said Gianluca Botto, head of electrophysiology and clinical arrhythmias at S. Anna Hospital, Como, Italy and president of Italian Association of Pacing and Arrhythmias. 

Boston Scientific said that it is seeking regulatory approvals for revised labeling and updated software for systems using its EnduraLife battery technology in major markets by 2017.

ImageReady capabilities will be added to virtually all high-voltage products currently marketed, including Autogen, Dynagen, Inogen and Origen devices, as well as Acuity X4 quadripolar left ventricular (LV) leads, Ingevity and Fineline II pacing leads, and Reliance 4-Site  and 4-Front defibrillator leads.

For more information: www.bostonscientific.com

Related Content

HeartVista Announces One Click Autonomous MRI Solution
News | Magnetic Resonance Imaging (MRI) | November 25, 2018
HeartVista announced its artificial intelligence (AI)-driven, One-Click Autonomous MRI acquisition software for cardiac...
Carotid Artery MRI Improves Cardiovascular Disease Risk Assessment
News | Magnetic Resonance Imaging (MRI) | October 23, 2018
Magnetic resonance imaging (MRI) measurements of wall thickness in the carotid arteries improve cardiovascular disease...
FDA Clears Magnetom Sola 1.5T MRI From Siemens Healthineers
Technology | Magnetic Resonance Imaging (MRI) | October 09, 2018
The U.S. Food and Drug Administration (FDA) has cleared the Magnetom Sola, a 1.5 Tesla magnetic resonance imaging (MRI...
Stress Cardiac MRI Shows High Prognostic Value for Suspected Ischemia Patients
News | Magnetic Resonance Imaging (MRI) | September 17, 2018
Raymond Kwong, M.D., MPH, from the Harvard Medical School recently presented his findings on a study of how single-...
Rapid Cardiac MRI Technique May Cut Costs, Boost Care in Developing World
News | Magnetic Resonance Imaging (MRI) | August 29, 2018
A newly developed rapid imaging protocol quickly and cheaply diagnosed heart ailments in patients in Peru, according to...
High Prevalence of Atherosclerosis Found in Lower Risk Patients
News | Magnetic Resonance Imaging (MRI) | June 08, 2018
Whole-body magnetic resonance angiography (MRA) found a surprisingly high prevalence of atherosclerosis in people...
A cardiac MRI scanner at the Houston Methodist DeBakey Heart and Vascular Center. There is growing concern that gadolinium contrast may cause chronic health problems in some patients.

A cardiac MRI scanner at the Houston Methodist DeBakey Heart and Vascular Center. There is growing concern that gadolinium contrast may cause chronic health problems in some patients.

Feature | Magnetic Resonance Imaging (MRI) | February 28, 2018 | Dave Fornell
One of the biggest concerns in radiology in recent years is the safety of gadolinium-based contrast agents (GBCAs) us
Contrast-Free Cardiac MRI May Better Assess Need for Mitral Valve Surgery
News | Magnetic Resonance Imaging (MRI) | February 27, 2018
A new study published in the Journal of the American College of Cardiology confirms non-invasive cardiac magnetic...
The FDA has cleared the Toshiba Vantage Galan 3.0T XGO Edition MRI from Canon Medical Systems.
Technology | Magnetic Resonance Imaging (MRI) | February 12, 2018
February 12, 2018 — Physicians now have access to more neuro and cardiac ...
Overlay Init