LivaNova and MicroPort Receive CFDA Approval of Rega Pacemakers

LivaNova PLC and MicroPort Scientific Corporation said the companies’ Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. has obtained approval for its family of RegaTM pacemakers from the China Food and Drug Administration.
 
Not only are Rega pacemakers the first manufactured by MSC, they are also China’s first domestically manufactured pacemakers that meet international standards. Measuring only eight cubic centimeters, Rega pacemakers are the smallest on the Chinese cardiac rhythm management (CRM) market. The devices feature advanced functions, such as a pacing mode that preserves intrinsic conduction, a dual sensor based response rate to exercise and sleep apnea monitoring.
 
“This is an important milestone achieved by MSC, our joint venture in China,” said Qiyi Luo, MicroPort’s chief technology officer. “The release of Rega pacemakers will strengthen our local presence and expand our footprint in China.”
 
“The approval of Rega pacemakers represents a large opportunity within the rapidly growing, underpenetrated Chinese CRM market,” said Benoît Clinchamps, LivaNova’s vice president and general manager of its CRM business franchise. “China has more than 1 million bradycardia patients who can be treated with an implantable pacemaker, with an estimated 300,000 new cases annually. Due to the current high price of pacemakers in China, only about 80,000 patients are able to receive a pacemaker implant annually.”
 
”Rega pacemakers offer the Chinese patient a state-of-the-art technology at a significantly lower price than imported competing products,” said Li Wang, MSC’s CEO. “This is a game-changing value proposition for the Chinese patient.”
 
MSC is a joint venture established in 2014 between LivaNova and MicroPort. Through MSC, the two companies are collaborating on the import, sale and service of LivaNova CRM devices in greater China, as well as on the development and manufacturing of local CRM products. MicroPort holds a 51 percent stake in the joint venture entity, while LivaNova holds the remaining 49 percent interest.
 
MicroPort Scientific Corporation is a medical device company publicly listed on the main board of Hong Kong (HK853). The Group focuses on innovating, manufacturing and marketing high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one every 30 seconds in more than 2,000 major hospitals throughout China and more than 20 other countries, MicroPort maintains operations in a wide range of business segments, including cardiovascular, orthopedic, electrophysiological, endovascular, neurovascular, surgical management, diabetes care, and endocrinal management, among others.
 
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment. LivaNova’s advanced technologies and treatments provide  solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola, Italy; Houston, Texas; and Clamart, France, respectively.