Mainstay Medical Holdings plc today announced that the U.S. Food and Drug Administration (FDA) has approved conditional whole-body MRI labeling for the ReActiv8® restorative neurostimulation system. This approval applies to all current and future ReActiv8 patients in the United States implanted with the commercially available 45cm leads.

The approval allows patients with ReActiv8 implants to undergo 1.5T whole-body MRIs. Scan specifications and safety information are provided in the FDA ReActiv8 MRI Instructions Manual.

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Contacts

Mainstay PR and IR Inquiries:

LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel.: +353 86 602 5988
Email: mainstay@fticonsulting.com

Mainstay Medical
Corporate Communication
Email: Media@mainstaymedical.com

Source: businesswire.com