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

  • March 2020
  • August 2015
  • December 2015
  • August 2014
  • September 2013
  • May 2013
  • May 2012
  • February 2010
  • October 2009
  • March 2008
  • February 2008

  • March 2020

    Xinsorb bio absorbable stent approved for listing

  • August 2015 - may 2016

    Completion: single group clinical study enrollment

  • December 2015

    Zhongshan Hospital, completed a long-term (36 months) animal experiment

  • August 2014 - August 2015

    Completion: randomized controlled clinical study was enrolled

  • September 2013 - January 2014

    Completion: the FIM clinical study was enrolled

  • May 2013

    Obtain the inspection report of China Academy of food and drug control

  • May 2012

    Animal experiment for registration, and the experimental report was obtained in January 2013

  • February 2010

    Traditional Chinese medicine hospital, carry out animal experiment

  • October 2009 - October 2010

    Establish a quality system, officially set up a project, and carry out the design and development of biodegradable coronary stents

  • March 2008 - September 2009

    Set up workshop, purchase equipment and build team

  • 2008

    Establishment of the company

    Start the research of metal stent and degradable stent