Published on : Nov 10, 2015
Invibio has completed their biocompatibility testing in the China market, making way for the China Drug Administration and China Food approval and the local legal compliance for Invibio’s PEEK-Optima HA Enhanced spinal fusion implants. With the new and enhanced spinal fusion implant devices, the China medical devices industry is expected to reach new heights in the coming few years.
John Devine, the medical business director, said that Invibio is totally committed and interested in building their activities in various regions across China. With this, the company is planning to expand their portfolio of enhanced spinal fusion implant devices throughout the fast expanding medical devices market, where there is increasing demand for innovative medical solutions. Invibio is determined to work with leading and emerging manufacturers and companies in the medical devices market in a cost-effective manner, stated John. Reliable and proven surgical solutions will be provided to the manufacturers, added John.
Here are the Five Key Highlights:
- Invibio has been already offering new generation spinal implants to Europe and the U.S. Now China will also be a part of their offerings.
- Biocompatibility testing was successfully completed at the CFDA Tianjin Medical Device Supervision and Testing Center. The results are available on Delayed Type Hypersensitivity, Genotoxicity, In-vitro cytotoxicity, Skin Irritation, 26-week bone implantation, and Sub-chronic toxicity.
- The 26-week bone implantation test is considered to be significant as it is supposed to reduce the time required for approval of CFDA process.
- Some of the implants with the U.S. and Europe approval using PEEK-OPTIMA HA Enhanced includes cervical interbody fusion devices from Meditech Spine, EVOS from Cutting Edge Spine, and Arena-C HA from SpineFrontier.
- Invibio is planning to participate in the 10th International Congress of the Chinese Orthopedic Association and present their new PEEK-OPTIMA HA Enhanced implants.