Invibio completed biocompatibility testing in China, paving the way for China Food and Drug Administration approval and local legal compliance for the company's PEEK-OPTIMA HA Enhanced spinal fusion implants.
Here are five key notes:
1. Invibio already offers the new generation of spinal implants in the United States and Europe.
2. The biocompatibility testing was completed at CFDA Tianjin Medical Device Supervision and Testing Center with associated results available in reports released on Delayed Type Hypersensitivity, Skin Irritation, Genotoxicity, Systematic toxicity, In-vitro cytotoxicity, Sub-chronic toxicity and 26 week bone implantation.
3. The 26 week bone implantation test is significant because it will reduce the time involved in the application process for CFDA approval.
4. The implants with Europe and United States approval using PEEK-OPTIMA HA Enhanced include the Arena-C HA from SpineFrontier, cervical interbody fusion devices from Meditech Spine and EVOS from Cutting Edge Spine.
5. Invibio plans to participate in the 10th International Congress of the Chinese Orthopaedic Association and include PEEK-OPTIMA HA Enhanced.
"Invibio is absolutely committed to building our activities in China and extending our portfolio of implantable polymers to the fast developing market, where there is high demand for innovative solutions in just about every medical sector," said Medical Business Director John Devine. "We are determined to work with medical device manufacturers in a manner that is most cost-effective for them and supports them in providing reliable, proven solutions to surgeons quickly."