Boston Scientific receives CE Mark on MRI conditional labeling for CRT-D and ICD systems

Boston Scientific CorporationAug 25 2015

Boston Scientific Corporation (NYSE: BSX) 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 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.

"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," 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."

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-FRONT^™ defibrillator leads, gives Boston Scientific the largest portfolio of MRI-compatible products in Europe.

MRI compatibility has not received regulatory approval in all geographies.