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"We suspect it will help grow cells in the $1.5 billion interbody market segment in the US. We believe that because there’s a need this segment right now for improved technology."
--Amedica president and CEO Eric Olsen on the expanded claims of the company's interbody devices.
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PEEK has been a successful alternative to metals in the spine segment for several years. And while new uses continue to emerge, options beyond PEEK are also gaining recognition. Most recently, the expanded claims for Amedica Corp.’s (Salt Lake City) interbody fusion devices are confirmation that other enhanced materials exist as a viable option for spine surgeons. Amedica’s products use silicon nitride (Si3N4), a biomaterial that helps reduce the risk of infection, which can be a pesky problem for some patients. “I speak to a lot of patients who have had infected implants,” says Thomas Webster, PhD, professor and chair of the department of chemical engineering at Northeastern University. “[They tell me about] the pain they go through to have that implant removed and have another inserted—[and] many times there are cases of implants getting infected time and time again, for the same patient.”
In vivo and in vitro studies (published in Acta Biomaterialia and the International Journal of Nanomedicine) reveal that silicon nitride improves osteointegration and possesses “superior” antiinfection abilities compared to PEEK and titanium.
Webster, the lead study investigator, says the differences between silicon nitride and PEEK and titanium are “amazing”. In the in vivo studies, the investigators put bacteria on the samples, which were implanted into rodent skulls. After 90 days, no bone grew on PEEK and very little grew on titanium, and the bacteria were overtaking the implants on both. However, the silicon nitride Amedica sample showed a significant amount of bone growth after 90 days while also stopping bacteria growth.
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"Sometimes I hear from patients that they’ll never be the same after having an infected implant. It’s speaks to decreasing significantly the number of revision surgeries due to infection."
--Thomas Webster on the need for implants that have anti-infective properties.
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“For someone who has been in this field for about 15 years, what makes this amazing to me is that we didn’t use antibiotics,” says Webster. “We didn’t add a current antibiotic that an orthopedic surgeon would add if they saw signs of infection. This was just the raw chemistry, the raw surface properties of silicon nitride that made it a much better bone-growing material and antibacterial material than something like PEEK and titanium.” Silicon nitride is also semi-radiolucent, which helps with both accurate interoperative implant placement and tracking the implant postop.
Silicon nitride is used in all of
Amedica’s devices. Its first device was implanted in 2008, and the company has seen 8500 implantations since. “We’re looking to dramatically expand the sales of our interbody devices and to do that very quickly,” says Eric Olsen, president and CEO. “Our sense is that there’s no other material out there that has these types of claims that are based on published data in peer-reviewed journals.”
Amedica also has a CE mark for cancellous-structured ceramic (CSC), which is made from silicon nitride. The CSC is used in an interbody device that replicates hard cortical bone on the outside while the CSC mimics cancellous bone in the center. Its porous structure allows bone to grow into the material, facilitating more effective osteointegration. Olsen says the company is in the process of enrolling patients in a couple of clinical studies to determine the long-term benefits of the material.
Maria Fontanazza is managing editor at UBM Canon. Follow her on Twitter @mariafontanazza.
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