Haikou, China – On December 22, MicroPort Sorin CRM (Shanghai) Co., Ltd. ("MSC"), a joint venture of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), attended the 10th China International Pacemaker Summit ("CIPS") and hosted product launch of Rega™ Family Implantable Pacemakers with renowned pacemaker professionals in attendance. As the first domestically made world-class pacemakers in China, the official launch of Rega™ Family Implantable Pacemakers marks a milestone in the development of China's own pacemakers, which is expected to benefit a large group of domestic patients with its high quality and affordable price.
In September 2017, MicroPort® announced the approval of China Food and Drug Administration ("CFDA") for its Rega™ Family Implantable Pacemakers, making them the first domestically made world-class pacemakers in China. 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 disease management, 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.
Professor Shu Zhang, President of the Heart Rhythm Special Committee of Chinese Medical Doctor Association, said: "I'm very excited about the market launch of Rega™ Family Implantable Pacemakers, and I'm delighted for its contribution to China's cardiac pacemaker industry. The domestically developed pacemakers break the monopoly of imported devices, enabling more patients to afford pacemaker treatment. With government support for home-developed innovative medical devices, Chinese Medical Doctor Association will work together with MSC to jointly push the development of China's pacemaker industry."
Professor Congxin Huang, Former President of Chinese Society of Pacing and Electrophysiology of Chinese Medical Association, said: "The market launch of Rega™ Family Implantable Pacemakers is a milestone in China's cardiac pacemaker industry. I hope the devices will be well accepted in the China market to facilitate the work of clinicians and benefit patients."
Professor Dejia Huang, President of Chinese Society of Pacing and Electrophysiology of Chinese Medical Association, said: "I witnessed the launch of China's first domestic cardiac pacemaker production line with international advanced standards in 2015 and now the official launch of Rega™ Family Implantable Pacemakers in 2017, and I am looking forward to seeing the launch of a complete solution and other new achievements by MSC. As the government values innovation, Chinese Medical Association will partner with enterprises to jointly promote the development of China's medical technology through medical education in implant technique and patient management."
Professor Wei Hua, President-elect of Chinese Society of Pacing and Electrophysiology of Chinese Medical Association, said: "The market launch of Rega™ Family Implantable Pacemakers is the result of joint efforts by strong teams of R&D, manufacturing, and clinical affairs, which lays a solid foundation for the development of more innovative devices. At the same time, we will work closely with MSC in clinical research of pacemakers to accumulate clinical experience and promote the popularization of pacemaker treatment."
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. After this product launch, Rega™ Family Implantable Pacemakers had been put into clinical use. Dr. Li Wang, Chief Executive Officer of MSC and Fellow of Heart Rhythm Society, said: "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 to help improve the life quality for more domestic patients in China."
In November 2017, MicroPort® announced that the company will acquire LivaNova's Cardiac Rhythm Management ("CRM") Business Franchise for $190 million in cash. The transition is expected to be completed by the second quarter of 2018. Upon completion of the acquisition, MicroPort® will become the most advanced domestic company in China with CRM know-how in the global CRM market which is estimated to be $10 billion. This acquisition will transform the domestically made pacemakers from a market follower to a potential competitor to market top leaders. Based on the success of LivaNova's world-class CRM devices, MicroPort® will continue to develop innovative CRM devices for the China market with tailor-made treatment and service, to better serve the domestic patients.