Production approval by SFDA in June 2005.
Successful clinical trials performed at Shanghai Changzheng Hospital and Shanghai Zhongshan Hospital during July - December 2005. SFDA Product Registration approved in February 2006. ISO9000 & ISO13485 certified in February 2007. CE Approval in January 2008
Product & Technology
The Products
Indications
Symptoms:
VCF- Vertebrae Compression Fracture
Back pain
Spine deformity
Decline in pulmonary
function 肺功能減退
Anepithymia 食欲不振
Hyposomnia 失眠症
Less activities
Bone loss
Increase fracture risks
Much more influence on pulmonary function
Mortality increased by 23%
Percutaneous Kyphopasty Procedure (PKP)
Put the balloon catheter into the fractured vertebral body.
Inflate the balloon, restore the height of vertebrae and raise the endplate.
Vacuumize the balloon and remove, then fill in bone cement.
Research & Development
New Tools & Accessories Development
SPACER for Lumber Spinal Stenosis (LSS)
Clinical Trials Scheduled in October 2010
Market Projection
〜4,000 Cases in 2009
〜20,000 Cases in 2012
