LivaNova and MicroPort’s Shanghai-based joint venture—MicroPort Sorin Cardiac Rhythm Management—has obtained approval for Rega. The family of pacemakers is now approved by the China Food and Drug Administration.
Rega are the first pacemakers manufactured by the venture, as well as China’s first domestically manufactured pacemakers that meet international standards. Measuring eight cubic centimetres, Rega pacemakers are the smallest on the Chinese cardiac rhythm management market.
The devices include advanced functions such as a pacing mode that preserves intrinsic conduction. It also features a dual sensor-based response rate to exercise and sleep apnoea monitoring.
Benoît Clinchamps, LivaNova’s vice president and general manager of its Cardiac Rhythm Management business franchise, says, “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,” says Li Wang, MSC’s chief executive officer.