First Domestically Made World-Class Pacemaker Device Gains CFDA Approval

MicroPort Sorin CRM (Shanghai) Co., Ltd. ("MSC"), a joint venture of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), recently gained the regulatory approval from China Food and Drug Administration ("CFDA") for its Rega™ Family Implantable Pacemakers, making them the first domestically made world-class pacemakers to gain market approval in China, which is expected to benefit more local patients with high quality and affordable price.
Rega™ Family Implantable Pacemakers has three series (Orchidee™, Trefle™, and Rega™) with a total of eight models. "They are all automatic, physiologic pacing pacemaker devices that feature small size and long life span. Specifically, they are the smallest pacemakers available in market with only eight cubic centimeters in volume, and they have service life of 10 to 12 years, allowing them to meet the need of various patients," said Dr. Li Wang, Chief Executive Officer of MSC and Fellow of Heart Rhythm Society, "With world-class quality and affordable price, it is expected that these pacemaker devices can provide safe, efficacious and cost-effective high-end solutions and service to physicians and patients in China."
Since its establishment in 2014, MSC has stuck to its vision of "Innovated in China, for China," and has been taking solid steps in becoming a company combining "Made-in-China" and "Innovated-in-China." MSC has built up a complete production chain by bringing in internationally advanced technology platform and following criteria of ISO13485 Quality Management System for Medical Devices. For example, according to the requirements of its production chain, every product of Rega™ Family Implantable Pacemakers is made after over 50 production procedures and more than 20 quality assessments, to achieve world-class quality and function. Aside from Rega™ Family Implantable Pacemakers, MSC is also developing cardiac pacemakers, pacing leads, and pacing system analyzers based on China's clinical needs, and is actively pushing forward the clinical and regulatory progress of these products featuring scientific designs and high quality.
Currently, implanting pacemakers is the only effective way to reduce mortality and improve life quality of patients with bradycardia. There are around one million patients suffering from bradycardia in China with an estimated 300,000 to 400,000 new cases annually. However, due to lack of core technologies and industrialization experience, China almost solely relies on imports for pacemaker devices, the high price of which has deterred most patients with only 80,000 of them can be treated with pacemakers each year.
Since its establishment, MSC has gained high recognition and strong support from Chinese Society of Pacing and Electrophysiology ("CSPE"), Chinese Society of Arrhythmias ("CSA" ), and domestic cardiac pacing and electrophysiological clinicians. With joint effort, they are committed to breaking the monopoly of imported pacemakers and revolutionizing China's pacemaker industry from "Made-in-China" to "Innovated-in-China" by developing the world's first-class pacemakers with advanced quality and technological innovation to benefit domestic patients.