Boston Scientific has received CE mark on magnetic resonance imaging (MRI) conditional labelling for the current family of extended longevity and MINI implantable cardioverter defibrillator (ICD) and the X4 cardiac resynchronisation therapy defibrillator (CRT-D) systems. This revised labelling 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 labelling, 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,” says 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,” says Joe Fitzgerald, executive vice president and president of the Rhythm Management division of Boston Scientific. “We are seeking regulatory approvals for revised labelling and updated software for these systems in major markets by 2017.”