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August 25, 2015

Boston Scientific’s MRI revised labelling secures CE Mark for ICD and CRT-D systems

Boston Scientific has secured CE Mark approval for magnetic resonance imaging (MRI) conditional labelling for its current family of Extended Longevity (EL) and MINI implantable cardioverter defibrillator (ICD) and X4 cardiac resynchronisation therapy defibrillator (CRT-D) systems.

Boston Scientific has secured CE Mark approval for magnetic resonance imaging (MRI) conditional labelling for its current family of Extended Longevity (EL) and MINI implantable cardioverter defibrillator (ICD) and X4 cardiac resynchronisation therapy defibrillator (CRT-D) systems.

The revised labelling ensures that future patients and those already implanted with the systems are able to undergo MRI scans if indicated.

Boston Scientific Rhythm Management division 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 labelling and updated software for these systems in major markets by 2017."

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

Referred to as ImageReady MR Conditional devices, the new system labelling specifies conditions under which the systems are deemed safe for use in a MRI setting.

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With the addition of ImageReady capabilities to all high-voltage products currently marketed, including Autogen, Dynagen, Inogen and Origen devices, Boston Scientific now has the largest portfolio of MRI-compatible products in Europe.

Capabilities were also incorporated into ACUITY X4 quadripolar LV leads, Ingevity and Fineline II pacing leads, as well as Reliance 4-Site and 4-Front defibrillator leads.

While patients with implantable cardiac devices have access to an array of diagnostic imaging, including x-rays and CT scans, the company’s systems were not evaluated as MRI conditional.

Italian Association of Pacing and Arrhythmias president Gianluca Botto said: "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."

According to the company, MRI compatibility has not received regulatory approval in all geographies.

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