Boston Scientific heart devices approved for use with MRI

Boston Scientific has announced that a number of its heart devices have been approved in Europe for use with magnetic resonance imaging (MRI) technology.

Its current family of EL (Extended Longevity) and MINI implantable cardioverter defibrillator (ICD) and the X4 cardiac resynchronisation therapy defibrillator (CRT-D) systems have been CE Mark-approved for MRI-conditional labelling.

This revised labeling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated.

The firm is seeking to add MRI ImageReady capabilities to virtually all of its high-voltage products, including the Autogen, Dynagen, Inogen and Origen devices, as well as the Acuity X4 quadripolar LV leads, Ingevity and Fineline II pacing leads and Reliance 4-Site and 4-Front defibrillator leads.

Joe Fitzgerald, executive vice-president and president of the rhythm management division of Boston Scientific, said: "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."

The company says it now has the largest portfolio of MRI-compatible products in Europe, and is seeking regulatory approvals for revised labelling and updated software for several other systems in major markets by 2017.