development history
Shandong Hua'an is one of the medical device companies that developed biodegradable coronary stent products earlier in China. The product name to be registered: Xinxiang? Xinsorb? Bioabsorbable coronary rapamycin eluting stent system is an innovative product of the fourth generation technological revolution in cardiovascular field, which has been strongly supported by national, provincial and Municipal Drug Administration and local government。
The project supports obtained include：
National 863 Project (2011)
13 national key research projects (2016)
National Science and technology support program
milepost
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March 2020
Xinsorb bio absorbable stent approved for listing
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August 2015 - may 2016
Completion: single group clinical study enrollment
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December 2015
Zhongshan Hospital, completed a long-term (36 months) animal experiment
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August 2014 - August 2015
Completion: randomized controlled clinical study was enrolled
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September 2013 - January 2014
Completion: the FIM clinical study was enrolled
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May 2013
Obtain the inspection report of China Academy of food and drug control
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May 2012
Animal experiment for registration, and the experimental report was obtained in January 2013
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February 2010
Traditional Chinese medicine hospital, carry out animal experiment
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October 2009 - October 2010
Establish a quality system, officially set up a project, and carry out the design and development of biodegradable coronary stents
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March 2008 - September 2009
Set up workshop, purchase equipment and build team
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2008
Establishment of the company
Start the research of metal stent and degradable stent