LivaNova (NSDQ:LIVN) and MicroPort Scientific (HKG:0853) said today that the group’s joint venture, MicroPort Sorin Cardiac Rhythm Management Co., won approval for its family of Rega pacemakers in China.
The Rega devices are the first domestically manufactured pacemakers that meet international standards in China, the companies touted.
The pacemakers are the smallest on the Chinese cardiac rhythm management market, measuring just eight cubic centimeters. The devices include features like a dual sensor-based response rate to exercise, a pacing mode that preserves intrinsic conduction and sleep apnea monitoring.
“This is an important milestone achieved by MSC, our joint venture in China,” MicroPort’s CTO Qiyi Luo said in prepared remarks. “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,” Benoît Clinchamps, VP & GM of LivaNova’s CRM business unit, added.
“China has more than one 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,” MSC CEO Li Wang said. “This is a game-changing value proposition for the Chinese patient.”