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

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 ...
Russian Team Developing New Technology to Significantly Reduce MRI Research Costs
News | Magnetic Resonance Imaging (MRI) | January 16, 2018
January 16, 2018 — Researchers from the NUST MISIS Engineering Center for Industrial Technologies in Russia have deve
Videos | Magnetic Resonance Imaging (MRI) | December 13, 2017
Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pitt
GE Healthcare Launches Blanket-Like Air Technology MRI Coils
Technology | Magnetic Resonance Imaging (MRI) | December 13, 2017
GE Healthcare announced U.S. FDA 510(k) clearance of its new Air Technology, what it calls an industry-first suite of...
Toshiba Vantage Galan 3T XGO Edition MRI Features New Advanced Gradient
Technology | Magnetic Resonance Imaging (MRI) | December 11, 2017
Toshiba Medical, a Canon Group company, demonstrated the Vantage Galan 3T XGO Edition with the all-new Saturn X...
Toshiba Launches Vantage Elan Zen Edition MR for Enhanced Patient Comfort
Technology | Magnetic Resonance Imaging (MRI) | December 05, 2017
Toshiba Medical, a Canon Group company, introduced its newest magnetic resonance (MR) system, the Vantage Elan/Zen...
FDA Clears Siemens Magnetom Terra 7T MRI Device

The FDA has cleared the Siemens Magnetom Terra as the first 7T MRI system in the U.S. to gain regulatory approval.

Technology | Magnetic Resonance Imaging (MRI) | October 12, 2017
The U.S. Food and Drug Administration (FDA) cleared the first 7 Tesla (7T) magnetic resonance imaging (MRI) device,...
MR Solutions Showcases Multimodality MRI Solutions on Two Continents
News | Magnetic Resonance Imaging (MRI) | October 11, 2017
MR Solutions took their cryogen-free preclinical multimodality magnetic resonance imaging (MRI) solutions on tour in...
Toshiba Showcases MRI Workflow Enhancements at RSNA 2017
News | Magnetic Resonance Imaging (MRI) | September 21, 2017
September 21, 2017 — Toshiba Medical will highlight its latest...
Overlay Init