DUBLIN--(BUSINESS WIRE)--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.

都柏林--（商业新闻短讯）--Mainstay Medical Holdings plc今天宣布，它已获得欧盟，英国和澳大利亚的监管部门批准，用于ReActiv8®恢复性神经刺激系统的全身MR条件标签。因此，欧洲和澳大利亚所有目前和未来的ReActiv8患者植入市售的45厘米导线，都能够进行1.5T全身扫描。

Specific scan conditions and safety information are provided in the ReActiv8 MRI Guidelines manuals for each territory.

ReActiv8 MRI指南手册为每个地区提供了具体的扫描条件和安全信息。

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.

MRI批准是在其公告机构颁发的主干接收证书方面取得的，该证书确认符合欧盟和英国的医疗器械法规（MDR）。

“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.

Mainstay Medical首席执行官杰森·汉农（JasonHannon）表示：“这些MRI批准将使我们能够显着扩大欧洲和澳大利亚患者在植入后可能需要（或发展需要）MRI成像的ReActiv8的使用范围，补充我们之前在美国批准的MRI标签。”。

Customer information emails will be sent, and MRI Guidelines and related information will be available, next week.

下周将发送客户信息电子邮件，并提供MRI指南和相关信息。

About ReActiv8®

关于ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery.

ReActiv8是一种植入式医疗设备，旨在治疗与多裂肌功能障碍相关的顽固性慢性腰痛（CLBP）的成年人。对于治疗失败（包括止痛药和物理治疗）且不适合脊柱手术的成年人，影像学或生理学检查可能会证明多裂肌功能障碍。

ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US..

ReActiv8已在多个地理区域获得监管部门的批准，并在欧洲经济区、澳大利亚、英国和美国上市。。

About Mainstay Medical

关于Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands..

Mainstay Medical是一家医疗器械公司，专注于将其创新的植入式恢复性神经刺激系统ReActiv8商业化，用于患有机械性CLBP的患者。Mainstay Medical总部位于爱尔兰都柏林，在爱尔兰、美国、澳大利亚、德国和荷兰设有子公司。。