Move over titanium (TI) and poly-ether-ether-ketone (PEEK)—there is a new challenger on the block. Salt Lake City, Utah, based Amedica Corporation announced on September 13 enhanced biomaterial claims based on newly published data for the company’s proprietary competing silicon nitride biomaterial.
Traditional treatment for the 65 million Americans who suffer from lower back pain includes implanting metal or plastic spacers between the vertebrae .While these spacers provide bone support and reduce pain; they do not actively participate in the bone fusion process and lack anti-infective characteristics. This is where silicon nitrides comes in.
Amedica’s new claims for silicon nitrides are based on peer-reviewed reports that silicon nitride’s hydrophilic surface demonstrates superior new bone growth and bacterial-resistant properties—greatly reducing the risk of infection—when compared to traditional treatments using titanium (Ti) or poly-ether-ether-ketone (PEEK.)
According to Amedica officials, researchers writing in the International Journal of Nanomedicine found that silicon nitrides is far less vulnerable to bacterial colonization (S. epidermidis, S. aureus, P. aeruginosa, E. coli and Enterococcus) than are PEEK and titanium. Because of the positive surface charge, nanostructure and hydrophilic nature of silicon nitride, there was also rapid adherence of fibronectin, vitronectin and laminin proteins which can decrease susceptibility to bacteria and increase osteointegration.
Researchers writing in the journal Acta Biomaterialia (2012) reported that the amount of regenerated bone associated with the silicon nitride implants was essentially two- to three-times that of the other two implant materials at three months post-surgery. After 14 days, silicon nitride demonstrated significantly greater new bone formation at both the surgical site and the implant interface.
Thomas J. Webster, Ph.D., lead investigator, chair and professor of the Department of Chemical Engineering at Northeastern University, said, “Selectively engineering the biomaterial or surface structure of the implant can decrease bacterial adhesion, therefore lessening the risk potential for infection. Our study examined the innate biomaterial characteristics of silicon nitride, PEEK and titanium, and it was evident that silicon nitride holds the greatest potential for decreased risk of bacterial infection.”
“The expansion of these biomaterial claims to our silicon nitride interbody fusion devices demonstrates the clear superiority of our technology in comparison to PEEK and titanium,” said Eric K. Olson, president and CEO, Amedica. “The company is prepared to take advantage of these enhanced claims, to dramatically increase sale of our silicon nitride products and grow company revenue. Ultimately, we believe, this technology will become the new standard of care.”
New Tool Is A Cost-Effective Way To Detect
A computerized approach to examining patient bone X-rays for diagnosis of osteoporosis could side-step the subjectivity associated with visual examination, according to a new research paper in theInternational Journal of Biomedical Engineering and Technology published in October.
Neelesh Kumar of the Central Scientific Instruments Organisation in Chandigarh, India, and colleagues recognized that the bone disorder osteoporosis is on the increase but that diagnosis using X-ray images of the patient's skeleton often lead to false positives and false negatives because visual examination, no matter how expert, is subjective. They have now developed a new approach based on the digitization of the X-ray images and estimation of the bone porosity associated with osteoporosis based on a sophisticated computer algorithm. X-rays are used in four times out of five for the diagnosis of osteoporosis, usually where other more expensive or inconvenient tests such as dual X-ray absorptiometry (DXA) are precluded.
The World Health Organization (WHO) defines osteoporosis as "a skeletal disorder characterized by compromised bone strength predisposing a person to an increased risk offracture". X-ray examination usually confirms the diagnosis at the severe or late-stage of development. However, a computerized system could allow much earlier diagnosis to be made and so give patients the opportunity to be treated more successfully before the disorder becomes a potentially debilitating illness.
The addition of a reference index to the X-ray image is key to the success of the new computerized technique. In conventional methods, the X-ray source quality, the film and its processing quality are possible sources of error but in the new system these sources are all but removed by the digital index on the film, the team says.
The team has tested the system on 40 elderly Asian patients with known diagnoses. 9 out of 10 of the females had osteoporosis, almost two-thirds of the men. The error rate is less than 2 percent, the team says. The team has begun the compilation of a knowledge base contained validated X-ray images to which the computer algorithm compares new X-rays. This database can be added to with new verified images once a definitive diagnosis has been made and so the system will improve with use.
"The new tool is a cost-effective solution, as it uses the existing facilities available in hospitals and thus, imparts no extra financial burden on healthcare providers or patients for quantitative estimation of osteoporosis," the researchers say. They point out that the same computerized diagnosis could be adapted to analyze bone deformity, scoliosis measurement, X-ray cracks and fractures.