Vallum’s PEEKplus® – The First and Only FDA Cleared Nanotexture on PEEK Interbody Fusion Devices.
Our truly disruptive PEEKplus® IBDs are the result of years of dedicated work and contributions by surgeons, biomedical and ion beam scientists, designers, engineers, technicians and investors. A substantial investment in time and capital have gone into developing ANAB processing technology and nano-processing techniques and protocols to create our highly advanced PEEKplus® nanotextured PEEK IBDs.
PEEKplus® nanotexturing is not a coating, it is not porous, and no chemicals are infused into the PEEK. Because of that, there is no potential for delamination, weakening or untoward tissue reactions from PEEKplus®.”Rather, nano-scale concavities of 20-50 nanometers are formed by the impact of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus®. Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.
Device-to-Device ANAB Process Repeatability: The ANAB processor is monitored and controlled device-to-device to ensure the surface of each PEEK IBD receives the same ANAB dose during processing. The ANAB processor is a fully automated, high-volume production tool with ultra-precision device-to-device control of the surface topography. Further, ANAB processing is ultra-clean and particle free with design and process controls that meet the highest requirements for medical device manufacturing.
ANAB processing additives, without subsurface damage and without altering device integrity or properties.
The ANAB Processor:
- Rockwell Automation control software was chosen for its field-proven and industry-accepted reliability.
- The control software is designed with a touch screen Human Machine Interface (HMI).
- The use of the tool is recipe driven and has full process control monitoring and full access to historical data.
- The entire multi-stage vacuum system utilizes industry recognized vacuum pumps, valves and gauges.
- The highly controlled gas delivery system incorporates 99.999% research purity (6.0) argon gas. Middlesex Gases in Everett, MA, is our exclusive supplier for the argon gas. Middlesex Gases is accredited with ISO/IEC 17025:2005, an International Standard designed for the accreditation of Testing and Calibration Laboratories. It includes quality management system requirements along with technical requirements to ensure that each laboratory is equipped to perform particular tests and calibration activities. Additionally, its filling facilities are FDA registered to fill medical cylinders. If the company should change its supplier of gas, the same specification as described above will be required by any new supplier.
- The ANAB processor’s gas delivery system and vacuum chambers are made from high purity stainless steel.
- The ANAB processor is operated in a certified class 7 cleanroom.
- ANAB processor is an additional manufacturing step for the IBD and is performed last; the entire manufacturing process prior to ANAB processing is identical to the predicate device.