Xianjian Technology Company is pleased to announce that it has received a notice from the State Food and Drug Administration (CFDA) on August 19, 2016 that its HeartToneTM implantable cardiac pacemaker products have been approved by the State Food and Drug Administration (CFDA). After the review, it entered the special approval process for innovative medical devices, namely the “green channelâ€.
The innovative medical device special approval process (“Green Channelâ€) is one of the important supporting measures for CFDA to encourage and promote the development of medical device research and innovation in China. The HeartToneTM Implantable Cardiac Pacemaker is the fourth product from the company to enter the CFDA's innovative medical device approval process. Zeng Lepeng, Chief Medical Officer of Xianjian Technology Co., Ltd. said: “The green channel is an important milestone in the company's cardiac pacemaker program. It allows us to communicate with CFDA on the clinical strategy of the product and optimize it while ensuring scientificity. The economic cost and time cost of the clinical strategy. At the same time, the CFDA will also arrange special personnel for our pacemakers to exchange and guide other problems existing in the enterprise, and give priority to the innovative products without reducing the standards and reducing the procedures. Therefore, entering the “Green Channel†will greatly reduce the uncertainty in the product registration process, effectively optimize the registration path of the HeartToneTM implantable cardiac pacemaker and significantly accelerate the time-to-market of products in China, enabling China Patients can benefit from domestic pacemakers as early as possible.
In July 2014, Xianjian Technology Co., Ltd. expanded its strategic cooperation with Medtronics, a global medical device giant and industry innovation pioneer. Medtronic is committed to providing the necessary technology, production, quality and product registration to support the company's research and development and production of high-quality, market-friendly plants that represent the world's leading technology in China. Heart-type pacemaker product HeartToneTM. In June of this year, Xianjian Technology Company completed the acceptance of the first pacemaker production line designed and constructed using Medtronic's advanced technology, and its quality level was recognized by Medtronic.
As the only effective treatment for bradycardia, cardiac pacemakers have irreplaceable clinical value. In recent years, the number of patients implanted with pacemakers in China is on the rise. According to the statistics of the Chinese Society of Electrocardiology and Pacing Society, the total number of pacemaker implants in China was about 70,000 in 2014. From 2008 to 2014, the annual growth rate of implants in China was 14%. Cardiac pacemaker products with advanced technology, high quality and affordable prices have huge market opportunities in China. After entering the "Green Channel", HeartToneTM will meet the needs of pacemaker implant treatment in Chinese arrhythmia patients in the near future, and will bring promising business benefits to Xianjian Technology.
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