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Boston Scientific gets CE mark approval for MRI conditional labeling of ICD and CRT-D systems

Boston Scientific has obtained CE mark approval for magnetic resonance imaging (MRI) conditional labeling of the current family of EL (extended longevity) and MINI implantable cardioverter defibrillator (ICD) and the X4 cardiac resynchronization therapy defibrillator (CRT-D) systems.

According to the company, the revised labeling helps future patients and those already implanted with these systems to undergo MRI scans if indicated.

Boston Scientific rhythm management division president and executive vice-president Joe Fitzgerald 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.

"We are seeking regulatory approvals for revised labeling and updated software for these systems in major markets by 2017."

A wide variety of diagnostic imaging, including x-rays and CT scans, is available to patients with implantable cardiac devices, but Boston Scientific systems had not been assessed as MRI conditional.

The new system labeling, denoted as ImageReady MR Conditional devices, specifies the conditions under which the systems are considered safe for use in a MRI setting.

In Europe, the firm’s MRI-compatible products include Autogen, Dynagen, Inogen and Origen, as well as Acuity X4 quadripolar LV leads, Ingevity and Fineline II pacing leads and Reliance 4-Site and 4-Front defibrillator leads.