MicroPort CRM Receives NMPA Approval for Next-Generation MRI-Safe Implantable Cardiac Pacing System

MicroPort Scientific Corp. (HKG: 0853), a leading Shanghai-based medical device company, has announced that its France-based subsidiary MicroPort Cardiac Rhythm Management Limited (MicroPort CRM) has received a market license from the National Medical Products Administration (NMPA) for its next-generation intravenous magnetic resonance conditionally safe implantable cardiac pacing system. The product suite comprises the ENO series implantable pacemaker and the Vega pacing electrode wire, which allow for a safe 1.5T/3.0T whole-body magnetic resonance imaging (MRI) scan post-implantation in patients.

The ENO series pacemakers approved in this latest regulatory nod include six models of single and dual chamber frequency responsive pacemakers, namely ENO, TEO, and OTO. These devices boast a compact volume of only 8 cubic centimeters and an anticipated service life of up to 12 years. The Vega pacing electrode wire is available in three different lengths to cater to various clinical needs. With the implantation of the pacing system, which includes the aforementioned pacemaker and pacing electrodes, patients will no longer face restrictions during MRI scanning, marking a significant advancement in patient care and safety.

This regulatory approval underscores MicroPort CRM’s commitment to innovation in cardiac rhythm management and its ongoing efforts to enhance patient outcomes through advanced medical device technology.- Flcube.com

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