Dalian, China, 24 August, 2021 — The first patient enrollment for the ‘China Pace’ post-marketing clinic study on the Rega® Family Implantable Pacemakers, developed by MicroPort Soaring CRM (Shanghai) Co., Ltd. (‘MSC’), was recently completed. The study, led by the First Affiliated Hospital of Dalian Medical University, is expected to carry out a one-year follow-up of nearly 1,000 subjects in 40 clinical centers across China, with the aim of evaluating the safety and efficacy of the Rega® Family Implantable Pacemakers in clinical practices, providing a solid basis for future research and development.
The three patients, who are all over 75 years old and reported different conditions, received implantation of three different Rega® pacemakers, including single-chamber and dual-chamber models. The procedures were performed smoothly by Prof. Yingxue Dong and Prof. Xiaohong Yu successively. All clinical indicators are so far normal and patients gave positive clinical feedback. This is the first large cohort study carried out on a domestic pacemaker after its launch, according to publicly available information.
Prof. Yunlong Xia, principal investigator of the study and President of the First Affiliated Hospital of Dalian Medical University, noted, “We are very pleased to have the first patient enrollment in our China Pace Study. Post-marketing studies are as important as pre-marketing research, as real-world clinical data can provide a better picture of clinical use and provide strong evidence for evaluating the safety and efficacy of a product. We hope to obtain more clinical evidence by expanding the scope of the study, to further demonstrate the technological breakthroughs we have made on pacemakers and promote the continuous optimization and incremental improvement of Rega® pacemakers.”
The world-class Rega® Family Implantable Pacemakers received marketing approval from the National Medical Products Administration (NMPA) in September 2017. Rega® pacemakers are automatic, physiologic pacing pacemaker devices with a volume of 8 cm3 and a life span of up to 10-12 years. They also feature a disease management function to accommodate the needs of different patients. Rega® pacemakers are small in size and well suited to the lean body type of Chinese patients. Since it was put into clinical use in March 2018, Rega® pacemakers have received full recognition from clinical experts.
Prof. Lianjun Gao, Director of the Cardiac Arrhythmia Center of the First Affiliated Hospital of Dalian Medical University, also expressed his high regard for the products, stating, “Domestic pacemakers have a long way to go. We look forward to positive progress in this study, and to the availability of more quality and versatile pacemakers developed for the benefit of thousands of patients and families.”
There are currently about 1 million patients suffering from bradycardia in China, with about 300,000–400,000 new cases each year. Only about 3%-5% of these patients receive treatments in China with about 66 pacemakers implanted per 1,000,000 patients. In comparison, the number of pacemaker implantation per 1,000,000 people is 1,000 in Europe and North America.[1]
Following the completion of patient enrollment, Xiaoming Zhu, General Manager of MSC, stated, “We would like to take this opportunity to strengthen our cooperation with clinical centers and doctors in China and to promote state-of-the-art technological development and manufacturing in the field of cardiac rhythm management by considering the clinical needs of Chinese patients and doctors, so as to provide more inclusive and accessible total medical solutions for the treatment of cardiac rhythm diseases.”
About MicroPort Soaring CRM (Shanghai) Co., Ltd.
MicroPort Soaring CRM (Shanghai) Co., Ltd. (“MSC”), is a subsidiary of MicroPort® Scientific Corporation (00853.HK). As a developer and manufacturer of medical devices in the field of cardiac rhythm management, MSC has always committed itself to innovation and research, to provide premium CRM products and services to patients in China and around the world. In the future, MSC will continue to further understand the clinical needs of Chinese patients and physicians, and to develop more targeted and refined treatment and management solutions to patients with heart diseases.
[1] Data source: An in-depth market analysis and industry development trend report on China’s pacemaker industry for 2020-2025. Published by Huaon Industry Research Institute.