Disclosure

12/8/2015
Recombinant Human
Growth Factor
Technology:
Designed for Today’s
Foot and Ankle Specialist
Gregory C Berlet MD, FRCS(C)
Disclosure
“The views, opinions and product experiences discussed
in this presentation, whether implicit or explicit, are
those of the presenting surgeon and do not
necessarily reflect the views and opinions of Wright
Medical Technology, Inc. Proper surgical procedures
and techniques are the responsibility of the medical
professional. Each surgeon must evaluate the
appropriateness of the procedures based on his or her
personal medical training and experience. Prior to use
of the system, the surgeon should refer to the product
package insert for complete warnings, precautions,
indications, contraindications and adverse effects.”
The speaker is a consultant of Wright Medical
MKS233-00
Autograft – Gold Standard ?
• Autograft is the current ‘gold
standard’, particularly iliac crest
graft, due to its mechanical and
biological properties
• But if we only need the biologic
stimulation, is it worth it?
• What are the known risks & costs
of graft harvest?
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12/8/2015
Bone Grafting Disadvantages
Bone grafting has been associated with the following clinical complications:
Abscess
Fracture
Neuroma
Donor Site Pain
Gluteal Gait
Paresthesia
Blood Loss
Hematoma
Scarring
Bone Spur
Hemorrhage
Sensory Loss
Dehiscence
Hernia
Seroma
Drainage
Infection (deep)
Swelling
Erythema
Nerve Injury
Vascular Injury
~50 articles in the recent literature
Complications : Bone Graft Harvest
Meta-analysis: 1138 patients1
Other Donor…
Wound Infection
7%
7%
Major Acute Complications
20%
Nonunion at 24 months
15%
Chronic Pain*
49%
0%
10% 20% 30% 40% 50%
% Autograft Pts Affected
60%
*49% donor site pain at 24 months (intensity 15-50%)
1Noshchenko
et al J Spinal Disord Tech, 2014
Is There a Safer Alternative to BG?
Dimitriou ( 2011) :
• Meta analysis: RIA and ICBG
• 92 articles / 6682 patients in database
 RIA complication rate = 6%
 ICBG complication rate = 19.4%
Dimitriou et al. Injury 42(2); 2011
2
12/8/2015
Continual Improvement…
When we have a problem:
Identify a need :
We need an alternative to autograft
Innovate to develop a solution:
Meets the unique needs of foot and ankle
Prove the solution with:
Clinical trials
Record of safety
Tissue Engineering: Tools
Tissue Engineering: Interdisciplinary science that
combines the principles of biology, chemistry,
physics and engineering
Osteoblasts
Chondroblasts
Fibroblasts
Scaffolds
- β-TCP (CaPO4)
- Collagen
Signaling Proteins
- BMP 2, 7
- PDGF
More Selective Tools
Platelet Derived Growth Factor ( PDGF)
Mitogenesis
Chemotaxis
Angiogenesis
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12/8/2015
AUGMENT® Bone Graft (rhPDGF-BB/β-TCP)
Beta-tricalcium phosphate granules
(β-TCP), 1000-2000 μm
–Osteoconductive scaffold to deliver
rhPDGF-BB locally
AUGMENT® Bone Graft (rhPDGF-BB/β-TCP)
rhPDGF-BB (0.3 mg/mL): recombinant
DNA technology
–crucial signaling molecule that stimulates
healing process1
–potent regenerative agent with an
established clinical history of bone
regeneration (GEM 21S®)
1Hollinger
JO. JBJS, 2008
21S®
GEM
is currently marketed by OsteoHealth, a division of Luitpold
Pharmaceuticals who also owns the GEM 21S ® trademark.
AUGMENT® Bone Graft (rhPDGF-BB/β-TCP)
β-TCP
rhPDGF-BB
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12/8/2015
β-TCP provides the Scaffold for New Bone
• β-TCP fosters the in-growth
of cells
• Chemical composition
similar to natural bone
(Ca:PO4)
β-TCP Cell
Attachment
• Resorbed over 3-9 months
and replaced with natural
bone
β-TCP No Cells
13
Platelet-Derived Growth Factor (PDGF)
Defined Mechanism of Action
1. PDGF recruits cells from surrounding
tissue (chemotaxis)
2. PDGF causes recruited cells to
multiply (mitogenesis)
3. PDGF stimulates the creation of new
blood vessels (angiogenesis)
14
PDGF: 3 Mechanisms
Chemotactic index
Chemotaxis
5 X difference
PDGF-BB: The most potent chemotactic agent for cells of
mesenchymal origin
Fiedler (Human MSCs) Journal of Cellular Biochemistry (2002)
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12/8/2015
Platelet-Derived Growth Factor (PDGF)
Defined Mechanism of Action
1. PDGF recruits cells from surrounding
tissue (chemotaxis)
2. PDGF causes recruited cells to
multiply (mitogenesis)
3. PDGF stimulates the creation of new
blood vessels (angiogenesis)
16
PDGF: 3 Mechanisms
Relative to control
Mitogenesis
(23 unique growth factors/cytokines)
5 X difference
PDGF-BB :The most potent mitogen for MSCs
Mesenchymal Stem Cells (Rabbit), 3H DNA Synthesis Assay,
Data from Ozaki Journal of Stem Cells and Development (2007)
Platelet-Derived Growth Factor (PDGF)
Defined Mechanism of Action
1. PDGF recruits cells from surrounding
tissue (chemotaxis)
2. PDGF causes recruited cells to
multiply (mitogenesis)
3. PDGF stimulates the creation of new
blood vessels (angiogenesis)
18
6
12/8/2015
Angiogenesis
PDGF: 3 Mechanisms
• Formation of new blood vessels from pre-existing vessels
• Regulated by expression of VEGF (a molecule closely
related in morphology to PDGF)
• PDGF Upregulates VEGF1
• Criticality of angiogenesis to healing process
• Deliver nutrients/oxygen
• Eliminate waste
• Permit physical ingress of cells
• Permit ingress of factors to direct healing
1 Bouletreau et
al, Plast Reconstr Surg (2002)
Clinical Evidence
rhPDGF-BB/β-TCP Clinical History
20
Proof of Efficacy: GEM 21S Periodontal Data
Pivotal Clinical Trial – Largest Periodontal
Baseline X-ray
•180 patients: 11 centers
•3 arms
®
• 0.3 mg/mL rhPDGF-BB/β-TCP (GEM 21S )
• 1.0 mg/mL rhPDGF-BB/β-TCP
• β-TCP/buffer solution (“active” control)
Healed bone
•6 month follow-up
•
•
Tissue attachment level
Bone growth
GEM 21S® has a similar composition as
AUGMENT® Bone Graft
21
7
12/8/2015
GEM 21S® Demonstrates Bone
Regeneration > TCP Alone
p < 0.001
70
p < 0.001
60
% Bone
Fill
50
TCP Control
40
30
GEM 21S
20
10
0
6 Months
24 Months
Nev ins, et al 2013
Journal of Periodontology
% B one Fill Was 1 of 6 Secondary Endpoints
GEM 21S® demonstrated superiority relative to
β-TCP alone at multiple time points
22
®
GEM 21S Bone Histology: Normal Bone
Section of molar
between roots
New bone
on right
New bone
adjacent to β-TCP
M el lonig 2009
I nt ernational Journal of Periodontics and Restorative Dentistry
Biopsies of patients treated with GEM 21S® exhibited
physiologically normal bone formation
®
GEM 21S Historical Safety
• Commercial History
 United States (approved 2005)
 Canada (approved 2006)
• Implanted in over 200,000+ patients
• No reports of ectopic formation related to the
use of GEM 21S®
24
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12/8/2015
Clinical Evidence
for
AUGMENT ® Bone Graft
Foot and Ankle: 3 Trials to Date
Pilot Study 1 (Canada)
Prospective, Open-Label Trial: 60 AUGMENT® Bone Graft
Patients vs. Literature-Based Autograft Control
Pilot Study 2 (US)
Prospective, Randomized, Controlled Trial: 20 Patients, 2:1
Randomization AUGMENT® Bone Graft vs Autograft
Pivotal Study (North America)
Prospective, Randomized, Controlled Trial: 434 Patients,
2:1 Randomization AUGMENT® Bone Graft vs Autograft
26
Pilot Study: Canadian Foot and
Ankle Fusion Trial
Principal Investigator
Timothy Daniels, MD
St. Michael’s Hospital
Toronto, ON
27
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12/8/2015
Canadian Foot and Ankle Fusion Trial (Pilot)
De sign
Prospective, open label, multi-center
First clinical use in F&A
Scope
3 centers, 60 patients, 9 month f/u period
Ind ication
Ankle, hindfoot, midfoot† fusion requiring
supplemental bone graft
Investigational
P roduct
AUGMENT® Bone Graft
(rhPDGF-BB/β-TCP)
•Smoking History: 30%
•Obesity (BMI ≥ 30): 38%
•Revision surgery: 33%
•Diabetes: 10%
•Patients with 1 or more risk factors: 65%
Risk Factors
P rocedure Location
†Note:
•Hindfoot/Ankle: 52%
•Midfoot: 43%
•Both: 5%
The US label does not include midfoot as an approved indication.
28
Plain Radiograph (2 of 4 aspects)
Population
Whole (N=60)
At Risk (N=39)
Week 24
46/54 (85%)
29/35 (83%)
Week 36
52/59 (88%)
32/38 (84%)
CT Scan (≥ 50% osseous bridging)†
Population
Whole (N=60)
At Risk (N=39)
Week 6
22/51 (43%)
15/34 (44%)
Week 12-16
44/59 (75%)
25/38 (66%)
Clinical Success (36 Weeks)††
Population
Whole (N=60)
At Risk (N=39)
Yes
54/60 (90%)
37/39 (95%)
No
6/60 (10%)
2/39 (5%)
†A
threshold for fusion similar that proposed by Coughlin (2006); ASSESSED BY BLINDED
RADIOLOGIST
††Defined
by subjects who were not recommended for rev ision surgery within 12 months of the
index procedure; rev ision rate comparable to historical control, (9%, Haddad et al, JBJS, 2007)
29
 Canadian Pilot Study 1
Prospective, Open-Label Trial: 60 AUGMENT® Bone
Graft Patients vs. Literature-Based Autograft Control
Conclusions:
• Overall results are consistent with the baseline
arthrodesis rate in ankle arthrodesis surgery
• 75% of patients demonstrated high degree of
osseous bridging at 3-4 months per CT scan
Daniels et al. FAI 31(6), 2010
30
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12/8/2015
Conclusions:
High risk populations :
– Reported non-union rates of 27-41%
– By comparison, this high-risk study
population performed well
• No device related serious adverse events judged
by the investigator to be caused by the device
Daniels et al. FAI 31(6), 2010
31
USA Foot and Ankle Pilot
Fusion Trial
Principal Investigator
Christopher DiGiovanni, MD
Brown University
Providence, RI
32
USA Foot and Ankle Pilot Fusion Trial
De sign
Prospective, Randomized, Controlled
Scope
3 centers, 20 patients
Ind ication
Investigational
P roduct
Risk Factors
P rocedure Location
Ankle, hindfoot fusion requiring
supplemental bone graft
AUGMENT® Bone Graft
(rhPDGF-BB/β-TCP)
•Smoking History: 40%
•Obesity (BMI ≥ 30): 50%
•Diabetes: 10%
•Patients with 1 or more risk factors: 40%
•Triple Arthrodesis: 45%
•Ankle: 35%
•Subtalar: 20%
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12/8/2015
USA Foot and Ankle Pilot Fusion Trial
Radiographic Results
Overall
(n=20)
AUGMENT®
Bone Graft
(n=14)
Autograft
(n=6)
Week 6
X-Ray (>3/4)
0/11 (0%)
0/4 (0%)
C T (>50%†) 7/18 (39%)
0/15 (0%)
5/13 (38%)
2/5 (40%)
X-Ray (>3/4) 6/15 (40%)
5/12 (42%)
1/3 (33%)
9/13 (69%)
3/5 (60%)
10/13 (77%)
3/6 (50%)
Week 12
C T (>50%†) 12/18 (67%)
Week 36
X-Ray (>3/4) 13/18 (72%)
†
>50% osseous bridging is a threshold for CT fusion similar that
proposed by Coughlin (2006), ASSESSED BY BLINDED RADIOLOGIST
34
USA Foot and Ankle Pilot Fusion Trial
C T Scan
(≥ 50% osseous bridging)†
Week 6 AUGMENT® Bone Graft
5/13 (38.5%)
Week 6 autograft
2/5 (40%)
P lain Radiograph
(2 of 4 aspects)
Week 24
46/54 (85%)
Week 36
52/59 (88%)
C linical Success††
Week 36
54/60 (90%)
†A
threshold for fusion similar that proposed by Coughlin (2006), ASSESSED BY
BLINDED RADIOLOGIST
† † Defined
by subjects who were not recommended for revision surgery within 12
months of the index procedure
35
USA Foot and Ankle Pilot Fusion Trial
 US Pilot Study
Prospective, Randomized, Controlled Trial: 20 Patients,
2:1 Randomization AUGMENT® Bone Graft vs
Autograft
Conclusions:
• CT and Radiographic Fusion were comparable
between both groups
• AOFAS, FFI, SF-12 and VAS Pain Scores FOR
SURGICAL SITE improved substantially and
equivalently
DiGiovanni et al. FAI 32(4), 2011
36
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12/8/2015
USA Foot and Ankle Pilot Fusion Trial
Conclusions:
•VAS Pain Assessment for HARVEST SITE demonstrated
significant pain through 36 weeks in 5/6 patients
•22% Reduction in OR Surgical Time for AUGMENT® Bone
Graft Group vs Autograft Group
•Comparable Union Rates for Both Groups
•Low rate of transient antibody production
•No device related serious adverse events judged by the
investigator to be caused by the device
DiGiovanni et al. FAI 32(4), 2011
37
AUGMENT® Bone Graft Pivotal Trial
• Largest PRC IDE clinical trial ever
performed in foot and ankle
– 414 treated patients
– 397 evaluable patients
– 37 clinical centers (USA/CAN)
• Positive FDA Advisory Panel, May 2011
– Safety
– Efficacy
– Risk/Benefit
*DiGiovanni C et al, JBJS 95(13), 2013
37 Principal Investigators Across North America
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Christopher W. DiGiovanni, MD (PI)
Sheldon Lin, MD
Judith Baumhauer, MD
Timothy R. Daniels, MD
Nick Abidi, MD
Jorge Acevedo, MD
Robert Anderson, MD
Gregory Berlet, MD
Christopher Bibbo, DO
Bradley Brainard, MD
Keith Donatto, MD
Mark Easley, MD
Andrew Elliott, MD
Wm Granberry, MD
Justin Greisberg, MD
Steve Haddad, MD
Tony Hinz, MD
Osarentin Idusuyi, MD
Juha Jaakkola, MD
Paul Juliano, MD
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Alastair S. Younger, MD
Mark A. Glazebrook, MD
John G. Anderson, MD
Johnny T.C. Lau, MD
David Katcherian, MD
Karl-Andre LaLonde, MD
Ian Le, MD
Thomas Limbird, MD
Richard Marks, MD
Andrew Murphy, MD
Steve Neufeld, MD
Mickey Pinzur, MD
Steve Raikin, MD
Lew Schon, MD
James Sferra, MD
Naomi Shields, MD
RJ Sullivan, MD
Michael Swords, MD
Brian Thomson, MD
Troy Watson, MD
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12/8/2015
Pivotal Trial Design Summary
Design
Prospective, randomized (2:1),
controlled
AUGMENT® Bone Graft : autograft
Enrollment
414 treated patients, 37 centers in NA
Indication
Hindfoot or ankle fusion requiring bone
graft
Study Hypothesis AUGMENT® Bone Graft is non-inferior to ABG
Primary Endpoint
Secondary
Endpoints
Regulatory Status
Percent of patients fused at 6 months
(≥ 50% osseous bridging via CT)
Clinical, functional, radiologic, quality of life,
and safety outcomes
Protocol approved by FDA and Health
Canada
Patient Demographics
All Patients
Augment
n = 414
n= 272
n=142
51% / 49%
47% / 53%
57% / 43%
Age (Mean)
57
56
58
BMI (Mean)
31
31
31
Traumatic Arthritis
48%
49%
45%
Primary Arthritis
36%
33%
39%
Rheumatoid
7%
8%
4%
Other
10%
9%
12%
Obesity (BMI>30)
49%
46%
54%
Smoking History
24%
25%
23%
Prior Surgery
23%
23%
23%
Diabetes
12%
11%
13%
Sex (M/F)
Autograft
Diagnosis
Risk Factors
75% of patients in both groups had risk factors for poor healing,
including smoking history, prior surgery, diabetes and/or obesity
No differences in treatment groups
41
Surgical Intervention
All Patients
Augment
Autograft
n = 414
n= 272
n=142
Ankle
38%
39%
38%
Subtalar
26%
25%
28%
Calcaneocuboid
1%
1%
0%
Talonavicular
6%
5%
7%
Double Fusion
8%
8%
7%
Triple Fusion
21%
22%
20%
Total # of Joints
597
394
203
1 – 3 cc
29%
29%
29%
4 – 6 cc
51%
52%
48%
7 – 9 cc
20%
19%
23%
Fusion Type
Graft Volume
No statistically significant differences
42
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12/8/2015
Volumes of AUGMENT ® Bone Graft
Utilized in Trial
Vo lume
Percent
1.5-3 cc
28.8%
4-6 cc
51.9%
7-9 cc
19.2%
Important NOT to over pack, but utilize the appropriate
amount of β-TCP needed to fill voids and defects. THEN
utilize ALL of the rhPDGF-BB solution from the kits opened
DiGiovanni C et al, JBJS 95(13), 2013
Pivotal RCT Results
24 Weeks Results: All Patients (397)
100
P=0.010
80
P<0.001
60
P=0.038
40
20
P<0.001
P<0.001
0
CT Fusion Rates - All Pa tie nts
(N=39 7)
CT Fusion Rates - All Joints
(N=59 7)
Clinical H ealing
AUGMENT® Bone Graft (N=260, 394)
Therapeutic Failue Rate**
Graft Harvest Site Pain
Autograft (N=137, 203)
*All P values are for non-inferiority, except for graft harvest site pain, which is for superiority.
**Therapeutic failure rate was defined as delayed union or nonunion requiring surgery or further
therapeutic intervention.
Note: FDA did not base its approval of AUGMENT® Bone Graft on radiologic findings
from the pivotal study, but instead relied on clinical outcomes.
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12/8/2015
52 Weeks Results: All Patients (397)
Chart Title
100
P=0.003
80
60
40
20
P<0.001
P<0.001
Therapeutic Failue Rate**
Graft Harvest Site Pain
0
Clinical H ealing
AUGMENT® Bone Graft (N=260)
Autograft (N=137)
*All P values are for non-inferiority, except for graft harvest site pain, which is for superiority.
**Therapeutic failure rate was defined as delayed union or nonunion requiring surgery or further
therapeutic intervention.
Equivalent Improvement in Clinical Outcomes
Clinical Outcomes Measures
Statistically Equivalent Improvements in Clinical
Outcomes Measures†
(Non-inferiority established)
Foot Function Index
AOFAS Ankle-Hindfoot
Score
SF-12 Mean PCS
Fusion Site Pain
Weight Bearing Pain
24 Weeks
Yes (p=0.012)
52 Weeks
Yes (p<0.001)
Yes (p<0.001)
Yes (p<0.001)
Yes (p<0.001)
Yes (p=0.001)
Yes (p=0.016)
Yes (p=0.015)
Yes (p<0.001)
Yes (p<0.001)
DiGiovanni C et al, JBJS 95(13), 2013
Safety Summary
35
p=0.194 †
30
rhPDGF-BB/β-TCP Subjects (%)
25
20
Autograft Subjects (%)
p=0.201 †
15
p=0.378 †
10
‡
p=0.354†
5
p=0.654 †
P<0.001†
P<0.001†
0
Serious Tx AEs
Complications w/
proc.
Surgical Comp./Inf
Chronic Harvest Site
Pain (12 Mo)
*Chronic Pain: ≥20mm on VAS
†The p-v alue was determined by means of a two-sided Fisher exact test f or a treatment difference based on subject counts.
‡There was one serious surgical inf ection at the site of the bone graf t harv est.
DiGiovanni C et al, JBJS 95(13), 2013
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12/8/2015
AUGMENT® Bone Graft Trial Overall Summary
• Largest, most rigorously controlled
and performed Level 1 RCT in F/A
history
• Establishes AUGMENT® Bone
Graft as a safe and effective
alternative to autologous bone graft
in hindfoot and ankle fusion surgery
DiGiovanni C et al, JBJS 95(13), 2013
Note: FDA did not base its approval of AUGMENT® Bone Graft on radiologic
findings from the pivotal study, but instead relied on clinical outcomes.
AUGMENT® Bone Graft
Indications For Use Statement*
AUGMENT ® Bone Graft is indicated for use as an
alternative to autograft in arthrodesis (i.e., surgical fusion
procedures) of the ankle (tibiotalar joint) and/or hindfoot
(including subtalar, talonavicular, and calcaneocuboid
joints, alone or in combination), due to osteoarthritis,
post-traumatic arthritis, rheumatoid arthritis, psoriatic
arthritis, avascular necrosis, joint instability, joint
deformity, congenital defect, or joint arthropathy in
patients with preoperative or intraoperative evidence
indicating the need for supplemental graft material.
*Summary of Indications, Contraindications, Warnings and Precautions included
at end of presentation or may be found in product Package Insert.
Ready-to-Use Autograft Alternative
Kit Components Provided
Sterile Packed
Granules Soaked in
rhPDGF-BB solution
(0.3mg/mL) intra-operatively.
NOTE: Graft mixture should be left undisturbed for 10 minutes before being
implanted to ensure optimal saturation of the β-TCP particles. Ensure that the
entire volume of both components is a homogeneous mixture. The product
should be implanted within one (1) hour of mixing the two components.
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12/8/2015
Product Preparation
Note: Any rhPDGF-BB liquid
remaining in the bowl after
implantation of a sufficient
amount of AUGMENT®
Bone Graft may then be
drawn up and used to
hydrate the already
implanted AUGMENT® Bone
Graft dispersed throughout
the fusion site
Surgical Technique Recommendations:
Tibiotalar Arthrodesis
1. Site Preparation
2. Debridement
Surgical Technique
3. Perforation
4. Feathering
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12/8/2015
Key Application Pearls from
Clinical Trials
Soaked granules must be packed into the
perforations and under the feathering
Ensure good bony apposition between surfaces to
be fused
AUGMENT® Bone Graft should be used in the
same general manner and volume as cancellous
bone autograft
NOTE: Do NOT irrigate application site once graft has been implanted.
Technical Note
IMPORTANT: In order to
enhance the formation of new
bone, AUGMENT® Bone Graft
should be placed in direct
contact with well-vascularized
bone. In order to optimize bony
fusion, AUGMENT® Bone Graft
should be implanted to fill all
osseous defects and gaps,
while ensuring that it does not
prevent direct bony apposition
of the articular surfaces
intended for fusion
Surgical Technique
6. Hydration with
Remaining rhPDGF
solution
7. Fixation & Closure
NOTE: Do NOT irrigate application site once graft has been implanted
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12/8/2015
Biologic Augments: Why?
• Higher risk patients
• More revision and
complex cases
• Cost pressures to get
it right first time
Why? Non Union
Ankle Fusion:
78 ankle fusions, avg follow up 4 years
Majority of the patients were post-traumatic
“In this study, the nonunion rate was 41%, the
worst in the literature.”
Highest incidence in patients with
plafond/talus fractures
.
.
.
.
Frey et al FAI 15(11); 1994
Why? Non Union
. Subtalar:
. 184 consecutive isolated subtalar arthrodesis
. Overall nonunion rate = 16%
. Nonunion rate: Nonsmokers – 8%
Smokers – 27%
. Nonunion rate in: Primary fusion – 14%
Revision fusion – 29%
Easley et al: JBJS A 82(5); 2000
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12/8/2015
Why? Patient Factors
• Co-morbidities
– Diabetes/Neuropathy
– Vascular
– Tobacco
– Obesity
Tools in My Practice
Osteoblasts
Chondroblasts
Fibroblasts
Scaffolds
- β-TCP (CaPO4),
- Collagen
Signaling Proteins
- BMP 2, 7
- rhPDGF-BB
Whatever it takes to get the job done!
My Practice 2015
Iliac Crest Bone Graft
• Very limited indications
• Occasionally for structural graft when
reconstructing large defects
• More commonly use allograft seeded with
bone marrow aspirate
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12/8/2015
My Practice 2015
AUGMENT® Bone Graft
• Excellent experience in the
USA trial
• I use as a first line agent in
ankle and hindfoot fusions
• Include in consent
Continual Improvement…
When we have a problem:
Identify a need :
We need an alternative to autograft
Innovate to develop a solution:
Meets the unique needs of foot and ankle
Prove the solution with:
Clinical trials
Record of safety
AUGMENT® Bone Graft
(rhPDGF-BB/β-TCP)
The FIRST AND ONLY
proven alternative to
autograft in ankle and
hindfoot arthrodesis
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12/8/2015
AUGMENT ® Bone Graft
PROVEN:
Level 1 evidence of safety & effectiveness as an
alternative to autograft in the largest F&A clinical
trial ever conducted.
LABELED:
Class III combination product specifically proven in
and labeled for ankle and hindfoot arthrodesis via a
rigorous PMA regulatory pathway.
UNIQUE:
The only biologic product specifically engineered,
proven and approved for ankle and hindfoot fusion.
SAFE:
Proven safe through multiple clinical trials and
successful commercial use since 2009* while
eliminating the proven risks, morbidities, and costs
associated with autograft harvest.
*Canada; Product also available in Australia/New Zealand since 2011
THANK YOU
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