FDAnews
www.fdanews.com/articles/167915-boston-scientific-gets-ce-mark-for-mri-compatible-pacemakers

Boston Scientific Gets CE Mark for MRI-Compatible Pacemakers

October 17, 2014

Boston Scientific said Thursday that its Accolade pacemakers have been CE-marked. The pacemakers allow patients to receive full-body MRI scans when implanted with the company’s Ingevity leads.

The Accolade pacemakers can be used in higher-energy scan sequences and feature a programmable MRI timer, according to the company. Joe Fitzgerald, executive vice president of Boston Scientific, said the new pacemakers will help doctors identify atrial fibrillation quicker and begin anticoagulation therapy to reduce the risk of stroke, he added. 

In addition to the Accolade line, Boston Scientific received CE mark approval for the Visionist and Valitude cardiac resynchronization therapy pacemakers. When paired with the company’s Acuity X4 pacing leads, those systems increase options for reaching and pacing the target location in the left ventricle, the Marlborough, Mass., devicemaker said.

Boston Scientific said it is actively pursuing MRI compatibility for other devices, such as implantable cardioverter defibrillators, cardiac resynchronization therapy defibrillators and lead technologies. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.