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China's original new generation of interventional heart valves approved for registration by CFDA

  • 2017-05-05

(Summary description)J-Valve Interventional Prosthetic Heart Valve" developed by Suzhou Jiecheng Medical Technology Co., Ltd. has been approved for marketing by the State Food and Drug Administration. It is the first original and internationally leading interventional heart valve in China, and the only product in the world that can effectively treat aortic valve insufficiency or stenosis.

China's original new generation of interventional heart valves approved for registration by CFDA

(Summary description)J-Valve Interventional Prosthetic Heart Valve" developed by Suzhou Jiecheng Medical Technology Co., Ltd. has been approved for marketing by the State Food and Drug Administration. It is the first original and internationally leading interventional heart valve in China, and the only product in the world that can effectively treat aortic valve insufficiency or stenosis.

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  • Time of issue:2017-05-05 16:02
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  J-Valve Interventional Prosthetic Heart Valve" developed by Suzhou Jiecheng Medical Technology Co., Ltd. has been approved for marketing by the State Food and Drug Administration. It is the first original and internationally leading interventional heart valve in China, and the only product in the world that can effectively treat aortic valve insufficiency or stenosis.
 
  The J-Valve heart valve can be automatically and precisely positioned according to the anatomy of the heart to replace the aortic valve in a minimally invasive catheter intervention. The unique positioning device cleverly addresses the key aspects of precise valve implantation and secure anchoring that have plagued the field of minimally invasive heart valves for years, overcoming the world's challenge that interventional valves cannot effectively treat aortic valve insufficiency. This technology avoids the drawbacks of traditional open-heart and conventional interventional valve replacement, resulting in shorter operative time, less trauma, faster postoperative recovery, and fewer complications, providing an effective treatment for elderly, high-risk patients.
 
  The J-Valve heart valve is an innovative special approval project under the State Food and Drug Administration's "Special Approval Procedure for Innovative Medical Devices (Trial)". The J-Valve heart valve is the first high-end medical technology that China has successfully exported to the western developed countries, and the approval of the J-Valve heart valve fully reflects the national policy of encouraging innovation and promoting the localization of medical devices.
 
  State Food and Drug Administration approval link: http://www.cfda.gov.cn/WS01/CL0403/172264.html
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