Mainstay Medical Holdings plc today announced that it has received regulatory approvals in the European Union, the United Kingdom and Australia for full-body MR conditional labeling for the ReActiv8® Restorative Neurostimulation system. As a result, all current and future ReActiv8 patients in Europe and Australia implanted with the commercially available 45 cm leads have the ability to undergo 1.5T full-body scans. Specific scan conditions and safety information are provided in the ReActiv8 MRI Guidelines manuals for each territory.
The MRI approvals were achieved in connection with Mainstay receiving certificates issued by its Notified Body confirming conformity with the Medical Device Regulations (MDR) of both the European Union and the United Kingdom.
“These MRI approvals will allow us to significantly broaden access to ReActiv8 for patients in Europe and Australia who may require (or develop the need for) MRI imaging post-implantation, complementing our earlier approval of MRI labeling in the United States,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “In addition, we are proud of our continued commitment to patient safety and product quality, as shown by our being among the first in the neuromodulation field to achieve MDR certification for Europe and the UK.”
Customer information emails will be sent, and MRI Guidelines and related information will be available, next week.
