First Homegrown MRI-Conditional Pacemaker Gets NMPA Marketing Approval

Shanghai, China, 28 April 2022 — MicroPort Soaring CRM (Shanghai) Co., Ltd. (MSC) has recently received the approval from China’s National Medical Products Administration (NMPA) for its Rega™ MRI-conditional implantable pacemakers. The Rega™ pacemaker series, which features advanced AutoMRI™ technology, is the first in China that is compatible with magnetic resonance imaging (MRI) examinations. Its launch will benefit more patients with pacemakers who require MRI exams for various reasons.

Rega™ pacemakers, with their small size, automation, minimizing ventricular pacing mechanism, and long working life, are the first domestic pacemakers of world-leading quality and have been widely accepted by doctors and patients since their approval in August 2017. To date, over 10,000 Rega™ pacemakers have been implanted, with the oldest patient being over 100 years old and the youngest only 22 months old. The approved Rega™ MRI-conditional pacemakers have been demonstrated safe after having undergone MRI conditional verification.

This pacemaker series has adopted the state-of-the-art AutoMRI™ technology, which allows them to automatically activate the MRI examination mode after detecting the magnetic field of an MRI device, and to immediately deactivate the MRI examination mode and restore prior settings after the patient leaves the MRI environment. This feature ensures that the pacemaker maintains the most optimal parameter settings feasible before and after an MRI examination, lowering patients’ discomfort and the risk of arrhythmias, and reducing physicians’ intervention workload. This product, when combined with the Beflex™ MRI-conditional pacing leads approved in January 2022, forms a complete MRI-conditional pacing system. Beflex® leads have been available in Europe for over 10 years with over 100,000 implants, and have received the CE marking in Europe for full-body MRI scans.

MRI is the gold standard for diagnosing illnesses associated with the central nervous system and musculoskeletal conditions. It is also the primary method for diagnosing abdominal and vascular diseases. With the further promotion of a hierarchical diagnosis and treatment system in China and the demand for digitization in primary medical institutions, MRI devices will continue to be widely used for the diagnosis of more diseases.

Mr. Jack Zhu, General Manager of MSC, commented, “The AutoMRI™-enabled MRI-conditional pacemaker is another major breakthrough for MSC after years of commitment in the field of cardiac rhythm management. As MSC‘s first MRI-conditional pacemakers, Rega™ will provide more options for clinical practices. MSC has been dedicated to the development and manufacture of medical devices linked to cardiac rhythm management since its founding in 2014, and has built a team with industry experience and strong R&D capabilities. MSC will continue to establish itself in the local market, fulfill clinical needs, and quickly deliver a family of heart rhythm management solutions to enable more patients with cardiac rhythm disorders to regain their health and improve their quality of life. ”

About MSC

MicroPort Soaring CRM (Shanghai) Co., Ltd. (MSC) is a subsidiary of MicroPort Scientific Corporation (00853.HK). MSC is a developer and manufacturer of medical devices in the field of cardiac rhythm management (CRM). MSC has always committed itself to the development philosophy of “Created in China” and “Made in China” to provide premium CRM products and services to patients. In the future, MSC will continue to meet the clinical needs of patients and doctors in China and offer more targeted and refined cardiology treatment and management solutions.