RTI Surgical® Announces The Spine Journal’s Publication of In Vivo TETRAfuse® 3D Technology PEKK Study
December 17 2019 - 7:05AM
RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical
implant company, today announced the publication of “A Comparative
Study of Three Biomaterials in an Ovine Bone Defect Model: A
TETRAfuse® PEKK Study” in The Spine Journal1. The study evaluated
the in vivo material characteristics of Polyetheretherketone
(PEEK), Titanium-coated PEEK (Ti-coated) and 3D-printed
Polyetherketoneketone (PEKK), TETRAfuse® 3D Technology.
PEEK, and more recently Ti-coated PEEK, have been used as
conventional biomaterial design choices for spinal interbody
implants. However, shortcomings in these materials, such as surface
delamination and lack of bone apposition, necessitated further
research into additional interbody material constructs, such as
TETRAfuse 3D Technology. TETRAfuse 3D Technology is featured in the
growing family of RTI’s Fortilink® Interbody Fusion Systems and has
a nano-roughii surface with antibacterial
characteristics†iii designed to participate in
fusioniv without compromising mechanical integrityii or
radiographic visibilityii.
“This study provided evidence of the potential advantages of
TETRAfuse 3D Technology related to bone growth characteristics
without sacrificing structural integrity,” said Dr. Boyle C. Cheng,
PhD, Director of Research in Neurosurgery at Allegheny General
Hospital in Pittsburgh. “In the ovine model, histological review of
TETRAfuse 3D Technology samples showed deeper implant
osseointegration and more notable trabecular bone ingrowth. There
is compelling evidence that PEKK offers preferable characteristics
to the more conventional interbody materials.”
Implants were analyzed post-implantation at 8 and 16 weeks with
respect to their osseointegrative capacities using a push-out
method, histological staining and various radiographic tests. Study
resultsv showed TETRAfuse 3D Technology implants demonstrating bone
ingrowth, no radiographic interference, no fibrotic tissue membrane
formation, a significant increase in bony apposition over time, and
a significantly higher push-out strength compared to standard
PEEK.
“The data from this hallmark ovine study in The Spine Journal
indicate TETRAfuse 3D Technology’s unique potential to improve the
effectiveness of spinal fusion procedures,” said Camille Farhat,
President and CEO, RTI Surgical. “We believe there are significant
opportunities for TETRAfuse to positively impact fusion, pain
reduction and long-term performance. We continue to invest in the
clinical data for this innovative interbody device material,
including our ongoing FORTE study, to demonstrate its preferred
characteristics and the positive impact it could have for spine
patients.”
In June 2019, RTI announced a milestone of 5,000 implants of
Fortilink®-C, -TS and -L IBF Systems with TETRAfuse 3D
Technology in the United States. TETRAfuse 3D Technology recently
won a 2019 MedTech Breakthrough Award for “Best New Technology
Solution - Orthopedics” and a 2018 Spine Technology Award
from Orthopedics This Week. For more information, please
visit www.tetrafuse3D.com.
References
i Cheng, PhD B, Jaffee S, Swink I, Averick, PhD S, Horvath S,
Zhukauskas, PhD R et al. A Comparative Study of Three Biomaterials
in an Ovine Bone Defect Model: A TETRAfuse® PEKK Study. The Spine
Journal. 2019. doi: 10.1016/j.spinee.2019.10.003
ii Data on file at RTI Surgical, Inc.
iii Wang M, Bhardwaj B, Webster T; Antibacterial properties of
PEKK for orthopedic applications. Int’l Journal of Nanomedicine.
2017: 12 6471-6476.
iv Data on file at RTI Surgical, Inc. Performance data from
animal studies may not be representative of performance in
humans.
v Industry funding was provided for the completion of this
research study, followed by an independent third-party review of
all relevant data for publication.
† Lab data may not be representative of the effects with
all bacteria or performance when implanted in humans.
Staphyloccocus epidermidis and Pseudomonas aeruginosa were subject
bacterial strains in this study.
Please refer to the labeling for clinical applications,
warnings, precautions and other instructions for use.
About RTI Surgical Holdings, Inc.
RTI Surgical is a leading global surgical implant company
providing surgeons with safe biologic, metal and synthetic
implants. Committed to delivering a higher standard, RTI’s implants
are used in sports medicine, general surgery, spine, orthopedic and
trauma procedures and are distributed in nearly 50 countries. RTI
has four manufacturing facilities throughout the U.S. and Europe.
RTI is accredited in the U.S. by the American Association of Tissue
Banks and is a member of AdvaMed. For more information, please
visit www.rtix.com. Connect with us
on LinkedIn and Twitter.
Steven Cohen Media Contact scohen@rtix.com +1
847 648 0861
Molly Poarch Investor Contact mpoarch@rtix.com
+1 224 287 2661
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