Boston Scientific (NYSE:BSX) said yesterday that it added MR-conditional labeling to the CE Mark for some of the defibrillators it sells in the European Union, claiming the title for Europe’s largest portfolio of MRI-compatible devices.
Marlborough, Mass.-based Boston Scientific said its EL extended longevity and Mini implantable cardiac defibrillators and the X4 cardiac resynchronization therapy defibrillators are now cleared to be labeled with the “ImageReady” brand. The company said the news means that nearly all of its high-voltage cardiac rhythm management devices and leads have MR-conditional clearance in countries recognizing the CE Mark.
“We are pleased to combine broader imaging options with our long-lasting, high-voltage portfolio, offering additional value to our exclusive EnduraLife battery technology for European physicians and their patients,” rhythm management president Joe Fitzgerald said in prepared remarks. “We are seeking regulatory approvals for revised labeling and updated software for these systems in major markets by 2017.”
“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,” added Dr. Gianluca Botto of the S. Anna Hospital in Como, Italy.
Boston Scientific said the list of its devices with the ImageReady label include the Autogen, Dynagen, Inogen and Origen CRM devices and its Acuity X4 quadripolar LV, Ingevity and Fineline II and Reliance 4-Site and 4-Front leads.