China's very own pacemaker hailed
China’s first domestically made pacemaker that meets international standards has been certified by China Food and Drug Administration for production in Shanghai’s Zhangjiang High-Tech Park in Pudong.
The pacemaker’s size is 8 cubic centimeters, making it the smallest such device on the Chinese market.
It is also about 30 percent cheaper than imported pacemakers, according to its manufacturer, MicroPort Sorin CRM (Shanghai) Co.
As most pacemakers in China are imported, the production of the home-developed device is also expected to challenge the domination of foreign pacemakers, the company added.
Imported pacemakers cost from 40,000 yuan (US$6,125) to 50,000 yuan, which is unaffordable for many Chinese patients.
The price of the RegaTM series pacemakers will be about 30 percent cheaper than the imported counterparts, said Wang Li, MicroPort’s chief executive. The local product also has a longer service life of 10 to 12 years, he said.
“We aim to offer safer, more effective and cost-efficient high-end products and services to more Chinese patients and physicians,” Wang added.
China has about a million bradycardia patients who need pacemakers implanted as the most effective treatment for them, with an estimated 400,000 new cases annually. Only 80,000 patients are able to receive the implant annually, mainly due to the high price, the company said.
About 540,000 people die of sudden cardiac arrest each year in China. The country started researching pacemakers in the 1960s, but the domestic production never amounted to much due to a lack of technical know-how.
Hong Kong-listed MicroPort Scientific Corporation and its Italian partner established a joint venture in 2014 and began researching on the domestically manufactured pacemakers under the international medical device quality management system.