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Medical Devices / Submissions and Approvals

Medtronic Snags Canadian Approval for ICD System With MRI Scans

Dec. 23, 2015
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Medtronic has scored Health Canada approval for its Evera MRI SureScan ICD system for use with magnetic resonance imaging scans.

An implantable cardioverter defibrillator, the system is licensed for MRI scans on any part of the body without positioning restrictions.

MRI restrictions have resulted in an unmet medical need, as patients could not receive scans with ICD systems due to potential interactions between the MRI and device function.

Canadian approval was based safety and efficacy data from a 275-patient clinical trial conducted in 42 centers around the globe. — Michael Cipriano