Medical Design Technology - November/December 2013

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Next Generation of GORE® Reinforced Medical Tubing

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Wall-Reinforced Medical Tubing

GORE® Spiral Wrap Tubing

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GORE® Braided Shafts

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High Pressure Braided Tubing

GORE® High Pressure Braided Tubing (HPBT)

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“Surgical site infections are a significant concern for surgeons. Approximately 600,000 interbody fusion surgeries are performed each year, and of those, up to 12% (or 71,000) will result in infection, costing hospitals an upwards of almost $7 billion dollars each year,” says Bryan J. McEntire, Chief Technology Officer of Amedica.

The risks involved in the use of IMDs is
costly and dangerous, with the possibility of
bacterial infections, which in turn can lead to
improper internal fusions, implant loosening,
complete device failure, and even death. Devic-
es composed of compatible, safe material is one
of the greatest means of reducing these risks.
To address this, Amedica has developed inter-
body fusion devices made of Silicon Nitride
(Si3N4), a proprietary biomaterial that has been
shown to promote bone on-growth. More im-
portantly, the material significantly minimizes
a patient’s exposure to infection. This is due to
the fact that silicon nitride exhibits less vulner-
abilities to bacterial colonization in comparison
to other traditional materials.

Another aspect proving the viability of Si3N4 is its strength. The biomaterial is the most fracture resistant ceramic commercially available. Si3N4 has also demonstrated osteointegrative characteristics, giving it greater clinical efficacy. The material is radiolucent, producing no MRI distortion or scattering under CT scans. This allows for optimum view for successful intraoperative placement and postoperative fusion assessment.

“The technology is on track to become the new standard of care for patients suffering from back pain and [for those] who require spinal fusion,” says McEntire.

Currently, Amedica is the only company with FDA clearance for the production of Si3N4 implants, with plans of integrating the proprietary material into other devices, such as hip and knee replacements and suture anchors. In particular, the Anterior Lumbar Interbody Fusion Device has received significant improvements through the use of Si3N4.

Conclusion

Aside from the latest concerns over device security, IMDs must overcome the primary risks related to cost, infection, power, and biocompatibility. The demand for implantable medicine is certainly growing, but true innovation remains stagnant, as designers seek to balance quality with safety, while striving to ensure cost efficiency. Upon analyzing current trends and demands, the real key behind overcoming these challenges appears to be in the exploration of entirely novel materials, components, and overall approaches. Current trends in the ICD market show the possibility of combatting present challenges through the reduction of device size, an improvement in battery power, and material composition advancements.