LivaNova and MicroPort's Rega pacemaker approved by the China FDA
27-Sep-17, Markets Insider
Livanova and MicroPort announced their Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management (MSC) has obtained approval for its family of Rega pacemakers from the China Food & Drug Administration. They are China’s first domestically manufactured pacemakers that meet international standards.
%20Shine.jpg "LivaNova and MicroPorts Rega pacemaker approved by the China FDA (c) Shine")
Image: Shine
"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," said Benoît Clinchamps, LivaNova’s Vice President.