GORE®;;1& 3'03."/$&; 5)306();*//07" 5*0/;;BOE;EF TJHOT;BSF;USBEFNBSLT;PG; 8;-;;(PSF;;;"T TPDJBUFT;;
Ü;;;;;;;;;;; 8;;-;;(PSF;;;"T TPDJBUFT;;*OD;;;;;"1;;;;;&/;;;;;/07&.#& 3;;;;;;
Next Generation of
GORE® Reinforced Medical Tubing
Wall-Reinforced Medical Tubing
GORE® Spiral Wrap Tubing
GORE® Braided Shafts
; t; 15'&;MJOFE;BOE;VOMJOFE;DPOmHVSBUJPOT
High Pressure Braided Tubing
GORE® High Pressure Braided Tubing (HPBT)
“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.
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