Plasmapore®XP - Aesculap Implant Systems

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Plasmapore®XP
Stability that Starts on the Surface
Aesculap Spine
Plasmapore®XP:
Stability that Starts on the Surface
Enhanced Implant Stability
Aesculap developed PlasmaporeXP to improve the stability
of PEEK interbody implants.
PlasmaporeXP is an innovative surface enhancing technology
designed to complement the PEEK interbody implant. The
roughened surface provided by PlasmaporeXP, a porous pure
Titanium and osteoconductive surface coating, increases
the migration resistance and mechanical strength of PEEK
interbody implants. PlasmaporeXP maximizes the contact
area between the implant and vertebral endplate, offering
surgeons the ideal scaffold for a stable fusion.
PlasmaporeXP Pure Ti coating over PEEK-Optima®*
Thickness: 60-150 µm • Porosity: 35-60% • Tissue-compatible
The PlasmaporeXP
Difference
Structure
The unique structure, properties and
processing of the PlasmaporeXP coating
result in unparalleled performance.
■
Pure Titanium
Coating for PEEK
35-60% Porosity
60-150 µm Thickness
■ 30 MPa Bonding Strength
■ 32 MPa Shear Strength
■ Roughened Surface
(Sa = 25.1 ± 1.65 µm)
■
■
■
Osteoconductive
■
Enhances stability
■
Improves imaging properties
■
Biocompatible
■
High adhesion strength
■
Increases migration resistance
*PEEK-Optima is a registered trademark of Invibio Biomaterial Solutions.
Performance
Properties
Processing
■
Proprietary 2-stage
Coating Process
Excellent Visibility
The Plasmapore®XP coating improves visibility of
PEEK interbody implants during imaging. PEEK is a
radiolucent material, allowing for visualization of bone
growth adjacent to the implant.
The addition of the PlasmaporeXP coating allows for
clear delineation of the implant contours during
imaging. The PlasmaporeXP coating does not create any
artifact in CT.
Lateral view of Arcadius®XP L
Lateral view of CeSpace™XP
Proven Biocompatibility
The PlasmaporeXP coating has proven biocompatibility and eliminates the fibrous tissue response
associated with PEEK implants.1
An animal study was performed in 2013 that examined comparative histological results at multiple time
points between PlasmaporeXP coated implants and PEEK implants. New bone formation, bony apposition,
inflammation, and fibrosis were measured as a percentage of each ovine bone sample. In summary, both
new bone formation and bony apposition were greater for the PlasmaporeXP coated implants than the
PEEK implants irrespective of time.2 In addition, significantly less inflammation and fibrosis was detected
for the PlasmaporeXP coated samples compared to the PEEK samples at all time points.2
Histology Images
F
B
F
Fig. A: PlasmaporeXP coated implant
Fig. B: Uncoated PEEK implant
B
Histology results at 12 weeks for
representative (Fig. A) PlasmaporeXP
coated implant to (Fig. B) uncoated
PEEK implant. There is increased
bone formation and apposition (B)
in the PlasmaporeXP coated implant
compared to the uncoated PEEK
implant. Increased fibrous connective
tissue (F) around the uncoated PEEK
implant is evident.
Improved Mechanical Properties
Increased Migration Resistance
3500
3000
2000
1500
1000
PlasmaporeXP is a migration-resistant surface enhancing
technology.
500
High Adhesion Strength
Mechanical testing was performed to evaluate the adhesion
strength of the Plasmapore®XP coating to PEEK interface.
Static tensile strength and static shear strength tests were
conducted according to a Center for Devices and Radiological
Health (CDRH) recognized industry guidance document for
metallic spray coatings.
Plasmapore was found to have a high adhesion strength to
the PEEK implant surface, exceeding the shear and tensile
strength of PEEK itself.3 In addition, the adhesion strength
of the PlasmaporeXP coating to PEEK interbody implants was
found to be strong enough to ensure continuous attachment.
Uncoated
PlasmaporeXP Coated
2500
Force (N)
The pullout strength of both PlasmaporeXP coated implants and
PEEK implants was evaluated in ovine bone samples at several
time points. The PlasmaporeXP coated implants were found to
have over six times the pullout strength at 12 weeks and over
nine times the pullout strength at 24 weeks compared to the
PEEK implants.2 No significant increase in pullout strength
over time was detected for the uncoated implants.2
Average Pullout Strength Results2
0
0
12
24
Weeks
Average Shear and Tensile Strength Testing Results3
35
XP
32.4
30.2
30
Mpa
25
20.0
20
22.0
15
10
5
0
Average Shear
Strength
PlasmaporeXP
Average Tensile
Strength
Industry Recommended Requirement
References:
1. “Evaluation of the Local and Systemic Reaction to a PlasmaporeXP Coated Implant in the Distal Femora of New Zealand White Rabbits,” Final Report
NP110102, Aesculap Internal Document, 2011.
2. Cheng, Boyle. Biomechanical pullout strength and histology of PlasmaporeXP Coated Implants: Ovine multi time point survival study.
Aesculap Implant Systems, Whitepaper, 2013 (ART129).
3. “Mechanical Testing Summary: Adhesion Strength of the Plasmapore®XP Coating to PEEK,” Aesculap Implant Systems, Whitepaper, 2013, (ART123).
Built on Experience:
The History of Plasmapore® Innovation
Plasmapore, the predecessor coating to PlasmaporeXP, was
first applied to cementless Titanium hip implants in 1986.
Plasmapore is a pure Titanium coating that offers an optimal
foundation for the ingrowth of bone due to its balanced
relationship between pore depth, porosity and roughness.1
remains prevalent in Aesculap’s evolving orthopedic and spine
product portfolios.
Dedicated to meeting the needs of the changing healthcare
environment, Aesculap identified an opportunity to improve
the stability of PEEK interbody implants. PlasmaporeXP is the
culmination of 30 years of innovation in spinal technology
and 20 years of experience with porous Titanium coatings.
In 1995, Aesculap expanded the application of the
Plasmapore coating to improve the primary and secondary
stability of Titanium spine implants. The Plasmapore coating
The XP in PlasmaporeXP stands for Experience.
1986
BiContact
Universal Hip
System
First application of Plasmapore
coating on Titanium hip prosthesis,
BiContact™ Universal Hip System*
1992
First clinical use of Plasmapore coated
hip prosthesis in the United States,
Plasmacup® acetabular cup system
1995
First Plasmapore coated Titanium
implant for the lumbar spine,
PROSPACE™ Titanium*
2000
2005
activL Lumbar Disc Prosthesis
Plasmacup Acetabular
Cup System
First Plasmapore coated Titanium
implant for the cervical spine,
CeSPACE™ Titanium*
Plasmapore µ-CaP coated total disc
replacement for the lumbar spine,
activL® lumbar disc prosthesis**
activC™ Cervical
Disc Prosthesis
2012
First PlasmaporeXP coated PEEK
lumbar spinal implant for the global
market, Arcadius®XP L Spinal System
Arcadius®XP L Spinal System
2014
*Not available in the U.S.
**Investigational use only
2007
Plasmapore coated total disc
replacement for the cervical spine,
activC™ cervical disc prosthesis*
2013
CeSpace™XP Interbody System
First PlasmaporeXP coated PEEK
cervical spinal implant for the global
market, CeSpace™XP Interbody System
ProSpace™XP Interbody System
PlasmaporeXP coated implant for
the posterior lumbar spine, ProSpaceXP
Interbody System
All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form.
In the case of misuse we retain the rights to recall our catalogs and price lists and to take legal actions.
©2014 AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA.
Aesculap is an equal opportunity employer
Aesculap Implant Systems, LLC | 3773 Corporate Parkway | Center Valley, PA | 18034
Phone 866-229-3002 | Fax 610-984-9096 | www.aesculapimplantsystems.com
Aesculap Implant Systems, LLC - a B. Braun company
DOC1119 Rev. A 2M 3/14

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