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Medtronic Revo MRI Pacer Approved, But Still Faces Reimbursement Hurdle

This article was originally published in The Gray Sheet

Executive Summary

Medtronic is hoping that the immediate U.S. launch of its newly approved Revo MRI SureScan MRI-compatible pacemaker will help boost market share in the device category, but magnetic resonance imaging scans of implant recipients still face a key reimbursement hurdle.

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St. Jude Medical last week announced two important regulatory approvals: a CE mark in Europe for its MRI-friendly pacemaker and an FDA PMA approval for its anticipated stented pericardial tissue heart valve device.

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