Boston Scientific Wins CE Mark for MRI Compatible Labeling for ICD, CRT-D Systems

Boston Scientific Corporation has won CE Mark approval 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. The revised labeling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if necessary.

Patients with implantable cardiac devices have a variety of diagnostic imaging available to them, including X-rays and computed tomography 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 in Como, Italy, and president of the Italian Association of Pacing and Arrhythmias. 

Adding ImageReady capabilities to virtually all high-voltage products currently marketed – which include Autogen, Dynagen, Inogen and Origen devices – as well as Acuity X4 quadripolar LV leads, Ingevity and Fineline II pacing leads and Reliance 4-Site and 4-Ffront defibrillator leads, gives Boston Scientific the largest portfolio of MRI-compatible products in Europe, executives claimed in a brief news release.

“We are pleased to combine broader imaging options with our long-lasting, high-voltage portfolio, offering additional value to our EnduraLife battery technology for European physicians and their patients,” said Joe Fitzgerald, executive vice president and president of the Rhythm Management division of Boston Scientific. “We are seeking regulatory approvals for revised labeling and updated software for these systems in major markets by 2017.”