Ventralex™ ST Hernia Patch

Ventralex™ ST
Hernia Patch
Featuring Sepra® Technology
Value Analysis Committee
Product Information Kit
SOFT TISSUE REPAIR
Right Procedure. Right Product. Right Outcome.
Bard Davol Overview
You are working with a leader – The Market Leader.
Over one million patients are treated for a hernia
across the U.S. each year, with cases ranging from a
simple inguinal repair, to complex ventral and abdominal
wall reconstruction. If a hernia is repaired with a mesh
device, there is a 50% chance it is a Bard Davol product.†
That is because Bard Davol is the leader in the hernia
repair market.
For a hospital, selecting a partner for hernia repair products
can be a difficult decision. There is a lot at stake for many
people in the organization, including Operating Room
Managers, Surgeons, Materials Management and of course
your patients. We are providing this Product Information
Kit, to simplify the selection process and to put pertinent,
important information at your finger tips.
Partnering with Bard Davol offers your hospital more than
just market-leading hernia products. Our commitment to
your success extends beyond the OR; we also offer
access to our Customer Service, Medical Services and
Support, Reimbursement Hotline and our world-class
Surgeon Education groups. These are resources Bard
Davol invests in for your success, staffed by experts who
are passionate about offering you the best service and
experience possible.
In addition to the benefits from our value added programs,
a partnership with Bard Davol provides you the opportunity to standardize your hernia products. This allows your
hospital to save money, streamline the ordering process
and eliminate product codes from multiple manufacturers
on the shelf, simplifying your inventory. Collaborating with
Bard Davol to standardize your mesh products can offer
significant savings:
“A $1.5 million savings over a
3-year period was achieved.”
Source: Formula for successful cost control includes hard data
plus surgeon champion. OR Manager (2014). 30(4):14-18.
A partnership with Bard Davol provides your hospital with
an edge, access to world-class products, services and
value add resources. You are working with a leader –
The Market Leader.
We support our customers in choosing:
RIGHT PROCEDURE. RIGHT PRODUCT.
RIGHT OUTCOME.
“3 out of every 4 umbilical hernias
are repaired using Ventralex™ mesh.”*
* Based on Ventralex™ and Ventralex™ ST units per IMS 4Q2013 and zero bed count hospitals, when a dedicated umbilical mesh is used.
†
50% market share, based on IMS 4Q2013 data.
Ventralex™ ST VAC Product Information Kit
Table of Contents
1. Product Introduction
A. Product Overview................................................................................2
B. 510(k) Clearance.................................................................................3
C. Instructions For Use..........................................................................4
2. Technical Data
A. Product Technology / Benefits.................................................6
B. Clinical Data.............................................................................................8
C.Sepra® Technology Publications............................................9
D. Economic Value................................................................................ 11
3.Reimbursement............................................................................ 12
4. Competitive Information
A. Competitive Overview................................................................. 13
B. Cross Reference Chart................................................................. 13
5. Material Management Information
A. Packaging Overview...................................................................... 14
B. Product Order Codes................................................................... 14
C. Conversion Process..................................................................... 14
6. Surgical Education.................................................................... 15
7. Value Added Programs..................................................... 16
1
1. Product Introduction
A.
Product Overview
A Proven Umbilical Hernia Repair Technique with an Absorbable Barrier
featuring Sepra® Technology
Easy:
Technique and Placement
• Simple tension-free intraabdominal repair.
• Minimum dissection and fixation required.
Efficient:
Positioning Pocket and Strap
• Pocket and strap facilitate placement, positioning
and fixation.
• SorbaFlex™ Memory Technology allows the patch
to “spring open,” lay flat to maintain shape.
• SorbaFlex™ Memory Technology absorbs over time.*
• Three sizes are available for coverage of larger defects
to smaller trocar site closures.
Proven:
Materials and Data
• Hydrogel barrier is based on Sepra® Technology.
• Uncoated monofilament polypropylene mesh allows
for complete tissue ingrowth leading to a strong repair.
• Clinically supported technique since 2002 with peerreviewed published clinical studies.
It begins with a hydrogel barrier.
It ends with a strong, long-term repair.
Sepra® Technology
An extensively studied barrier with more than
10 publications and used clinically since 2007.
nique hydrogel barrier swells to minimize tissue
U
attachment to the visceral side of the mesh. *
Bioresorbable PGA fibers reinforce the integrity
of the hydrogel barrier by binding it to the
polypropylene mesh.
The hydrogel barrier resorbs within 30 days.
* Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.
2
B.
510(k) Clearance
3
1. Product Introduction
C.
(cont.)
Instructions for Use
™
ST Hernia Patch
Self-Expanding Bioresorbable Coated Permanent Mesh Patch
and Strap for Soft Tissue Reconstruction
DESCRIPTION:
Ventralex™ ST Hernia Patch is a self-expanding bioresorbable coated, partially
absorbable, sterile prosthesis, containing 2 distinct layers stitched with PTFE monofilament, forming a positioning pocket and strap. The top layer is monofilament
™
polypropylene mesh and the bottom layer isSSepramesh
IP Composite mesh.
ORBAFLEX™ PDO
Sepramesh™ IP Composite is co-knitted usingMonofilament
polypropylene (PP) and absorbable
polyglycolic acid (PGA) fibers to result in a two-sided mesh with aSPP
surface ™ IP
EPRAMESH
Composite
and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable,
Monofilament
chemically modified sodium hyaluronate (HA),
carboxymethylcellulose (CMC) and
Polypropylene
polyethylene glycol (PEG) based hydrogel (see
Figure 1). Mesh
Fascial Side
Figure 1
INDICATIONS:
The Ventralex™ ST Hernia Patch is indicated for use in the reinforcement of soft
tissue, where weakness exists, in procedures involving soft tissue repair, including
repair of hernias and deficiencies caused by trocars.
CONTRAINDICATIONS:
1. Do not use the Ventralex™ ST Hernia Patch in infants or children, whereby
future growth will be compromised by use of such mesh material.
2. Do not use the Ventralex™ ST Hernia Patch for the reconstruction of
cardiovascular defects.
3. Literature reports that there may be a possibility for adhesion formation when
Visceral Side
the polypropylene is placed in contact with the bowel or viscera.
ST Hernia Patch
The fascial side of the mesh allows a prompt fibroblastic response ™
through the
interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral
WARNINGS:
side of the mesh is a bioresorbable
coating, separating
the mesh from underlying
Self-Expanding
Bioresorbable
Coated Permanent
Mesh
Patch sterile. Inspect the packaging to be sure it is intact and
1. The device
is supplied
tissue and organ surfaces to minimize
tissue for
attachment
to the mesh.
Shortly after
and Strap
Soft Tissue
Reconstruction
undamaged prior to use.
placement, the biopolymer coating becomes a hydrated gel that is resorbed from
2. This device is for single use only. Do not resterilize. Product should be used
the site in less than 30 days. A depth marker on the positioning strap for the small
once exterior foil pouch has been opened. Do not store for later use. Unused
Ventralex™ST Hernia Patch (REF 5950007) is designed to facilitate placement of the
portions of this prosthesis should be discarded.
small patch through a trocar.
3.
Do not cut or reshape any portion of the Ventralex™ ST Hernia Patch (as
™
this could impact its effectiveness), except for the polypropylene positioning
strap. Care should be taken not to cut or nick
the Sorbaflex™ PDO monoBioresorbable
SORBAFLEX™ PDO
™ Patch
coated side of
oresorbable Coated Permanent Mesh
™
filament. If the Sorbaflex PDO monofilament
is cut or damaged during
Monofilament
the prosthesis
Tissue Reconstruction
or fixation, additional complications
may include bowel or skin
IP
SEPRAMESH™insertion
Figure 2
Self-Expanding Bioresorbable Coated Permanent Mesh Patch
Composite
perforation and infection.
and Strap for Soft Tissue Reconstruction
Monofilament
4. Follow proper folding techniques for all patches as described in these
Polypropylene Mesh
Instructions for Use as other folding techniques may potentially compromise
™
Fascial Side
Side
Figure 1
the SorbaflexVisceral
PDO monofilament.
Figure
5. Ensure proper orientation; the bioresorbable coated
side of3 the prosthesis
Marker against the bowelMesh
Strap
shouldDepth
be oriented
or sensitive
organs. Do not place the
SORBAFLEX™ PDO
Monofilament
polypropylene side against the bowel. There may be a possibility for adhesion
formation when the mesh (including strap) is placed in direct contact with the
SEPRAMESH™
IP FLEX™ PDO
SORBA
Composite
Monofilament
bowel or viscera.
Monofilament
SEPRAMESH™ IP
6. To ensure a strong repair, the prosthesis should be secured with tacks or
Polypropylene Mesh
Composite
sutures through the polypropylene mesh straps or positioning pocket.
Monofilament
Visceral Side
Figure 1
7. Excess positioning strap material above the fixation line must be cut off and
Polypropylene Mesh
discarded to eliminate excess material from remaining in the body.
Fascial Side
Visceral Side
Figure 1
8. When used to repair deficiencies caused by trocars, the device should be used
under endoscopic guidance or direct visualization.
9. The use of any permanent mesh or patch in a contaminated or infected
The device contains Sorbaflex™ Memory Technology which provides memory
wound could lead to fistula formation and/or extrusion of the prosthesis.
and stability to the device, facilitating ease of initial insertion, proper placement,
10. If an infection develops, treat the infection aggressively. Consideration should
and fixation of the device. The Sorbaflex™ Memory Technology is comprised of
be given regarding the need to remove the prosthesis. An unresolved infection
an extruded polydioxanone (PDO) absorbable monofilament that is contained
may require removal of the prosthesis.
within a knitted polypropylene mesh tube. The Sorbaflex™ PDO monofilament fully
11. To prevent recurrences when repairing hernias, the prosthesis should be large
degrades in vivo by means of hydrolysis. The PDO monofilament has been found
enough to extend beyond the margins of the defect.
to elicit an inflammatory response during absorption. Absorption is essentially
ST Hernia Patch
ST Hernia Patch
complete in 6-8 months.
4
PRECAUTIONS:
1. Please read all instructions prior to use.
2. Only physicians qualified in the appropriate surgical techniques should use
this prosthesis.
3.
Care should be taken not to cut or nick the Sorbaflex™ PDO monofilament
during fixation.
4. The safety and effectiveness of Ventralex™ Bioresorbable
ST Hernia Patch has not been
side of
evaluated in clinical studies in the presencecoated
of malignancies
in the
the prosthesis
abdominopelvic cavity.
Figure 2
ADVERSE REACTIONS:
Possible complications include seroma, adhesions, hematoma, inflammation,
extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia
or soft tissue defect. If the Sorbaflex™ PDO monofilament is cut or damaged during
Figure 3
insertion or fixation, additional complications may include bowel or skin perforation
Depth Marker
Mesh Strap
and infection.
INSTRUCTIONS FOR USE:
Preparation
It is recommended that Ventralex™ ST Hernia Patch be completely immersed in
sterile saline for 1-3 seconds immediately prior to placement in order to maximize
the flexibility of the prosthesis. The safety and effectiveness of the Ventralex™ ST
Hernia Patch in combination with solutions other than saline have not been tested.
Surface Orientation
It is extremely important that this product be oriented correctly to function as
intended. The visceral side of the Ventralex™ ST Hernia Patch is designed to
temporarily separate tissue surfaces and minimize tissue attachment to the mesh.
Place the bioresorbable coated side of the prosthesis against those surfaces where
minimal tissue attachment is desired, i.e. against bowel or other visceral structures.
The uncoated polypropylene mesh side should face the surface where tissue
ingrowth is desired. The uncoated polypropylene mesh surface should never be
placed against the bowel or other visceral structures.
Hernia Repair
Select the patch that is approximately twice the size of the hernia defect. Fold the
patch parallel to the opening between the straps with the bioresorbable coated
side of the prosthesis facing out for insertion into the defect (see Figure 2). The
free or unattached end of the positioning strap remains outside of the body during
placement. The positioning strap is manipulated to facilitate the proper positioning
of the patch. Gently pulling up on the positioning strap will allow the patch to flatten
itself against the underside of the abdominal wall. The mesh positioning strap can
be pulled apart to gain access to the inner positioning pocket.
Fixation
To secure the patch, the mesh positioning strap is pulled up and apart and the
device is then secured to the margins of the defect through the strap or positioning
pocket. Bard® permanent or absorbable fixation devices or nonabsorbable
monofilament sutures are recommended to properly secure the prosthesis. If other
fixation devices are used, they must be indicated for use in hernia repair. Excess
positioning strap material above the fixation line must be cut off and discarded. The
method of securing the prosthesis should be determined by surgeon preference
and the nature of the reconstruction to provide for adequate tissue fixation and to
prevent reherniation.
Trocar Defect Repair with the Small Ventralex™ ST Hernia Patch
Fold the Ventralex™ ST Hernia Patch in half with the bioresorbable coated side of the
prosthesis facing out and hold it in the folded position with an endoscopic grasper.
Deploy the prosthesis all the way through the trocar and into the intra-abdominal
space. For a reference point, the small Ventralex™ ST Hernia Patch is constructed
with a depth marker (blue line) on the positioning strap 8 inches (203 mm) above
the patch (see Figure 3). A minimum 10 mm diameter trocar should be used to
introduce the patch. Release the prosthesis from the grasper when the patch is
completely through the trocar. The Sorbaflex™ PDO monofilament allows the patch
to open and lay flat in the intra-abdominal space. Pull up on the positioning strap
Bioresorbable
to hoist the prosthesis up to the distal end of the trocar. Pull
out the trocar and
coated
sidesure
of that the
pass it over the strap. Pull up firmly on the positioning strap
to make
the prosthesis
prosthesis is completely covering the defect. While pulling up on the positioning
Figure
2
strap, suture close the anterior fascia, catching
the positioning
strap in between the
margins of the fascia. Cut off excess positioning strap immediately above the suture
and discard.
Figure 3
Depth Marker
Mesh Strap
Trocar Defect Repair with the Medium or Large Ventralex™ ST Hernia Patch
Remove the trocar and follow the instructions found in the “Hernia Repair” and
“Fixation” sections above.
TRACEABILITY:
A traceability label which identifies the type, size and lot number of the prosthesis is
attached to every package. This label should be affixed to the patient’s permanent
medical record to clearly identify the device which was implanted. If you experience
a product failure, please contact Davol, Inc. at 1-800-556-6275 for instructions on
returning the product.
Bioresorbable
coated side of
the prosthesis
Figure 2
Bard, Davol, SorbaFlex and Ventralex are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Sepramesh is a trademark and/or registered trademark
of Genzyme
Figure
3 Corporation licensed to C. R. Bard, Inc. or an affiliate.
PK3795737
Depth Marker
115R
Mesh Strap
© Copyright 2014, C. R. Bard, Inc. All Rights Reserved.
5
2. Technical Data
A.
Product Technology / Benefits
Easy:
The Ventralex™ ST Hernia Patch’s simple technique is clinically proven for reliable umbilical
hernia repairs.
• Designed for intraabdominal repairs of umbilical and other
small ventral hernias.
• Intraabdominal placement eliminates lateral dissection
required for preperitoneal placement.
• Post-op pain may be reduced due to the minimal dissection
required to secure the prosthesis.
Ideal for trocar site closures.
Herniation into a trocar site, along with Richter’s hernias,
may occur even if the anterior fascia above the defect has
been closed. The smallest Ventralex™ ST Hernia Patch
allows for an intraabdominal, tension-free repair with no
transfascial suturing.
Efficient:
The Ventralex ™ ST Hernia Patch’s proven design aids placement, positioning and fixation.
Unique positioning pocket aids in proper
placement, positioning and lateral fixation.
Three sizes available for coverage of larger defects to
smaller trocar site closures.
6
Proven Material:
The Ventralex™ ST Hernia Patch combines bare polypropylene mesh together with a proven
hydrogel barrier, featuring Sepra® Technology.
Uncoated Monofilament Polypropylene Mesh
Sepramesh™ IP Composite2
• Over 40 years of proven results in hernia repair.
• Allows a fast fibrotic response for a strong repair.
• Provides a long-term repair with minimized recurrence.
• Hydrogel barrier is based on the Sepra® technology
with more than 10 publications and used clinically
since 2007.
- Unique hydrogel barrier swells to minimize tissue
attachment to the visceral side of the mesh.
- Resorbs within 30 days providing visceral protection
during the critical healing process.
• Bioresorbable PGA fibers reinforce the integrity
of the hydrogel barrier by binding it to the
polypropylene mesh.
Logarithmic regression curve of mean force of lap-shear
strength as a function of time. 74% of the 12 week
strength is achieved by 2 weeks post-operatively.1
Strength of Tissue Ingrowth In a Preclinical Study1
1.2
Mean Force (lbs.)
1.0
Cross Section View
0.8
0.6
0.4
0.2
0
0
2
4
6
8
10
12
Week
SorbaFlex™ Memory Ring Technology
• Polydioxanone (PDO) monofilament is commonly used
in other well-known surgical products (e.g. suture).
• Unique in its flexibility and tensile strength, it facilitates
patch insertion and proper placement.
• Absorption via hydrolysis is essentially complete in
24-32 weeks.2
Gross Explants
These images are
from a porcine study
using the Ventrio™
Hernia Patch which
contains the same
SorbaFlex™ Memory
Technology.
2
Majercik, S. et al. “Strength of tissue attachment to mesh after ventral hernia
repair with synthetic composite mesh in a porcine model.” Surg Endosc (2006)
20: 1671-1674. Results may not correlate to performance in humans.
2
Preclinical data on file at C. R. Bard. Results may not correlate to performance
in humans.
3
Dr. Matthews is a paid consultant for Davol. Financial support for the study
was supplied by Atrium Medical Corporation.
1
Bioresorbable coating
Sepramesh™ IP Composite Preclinical Study2
Pierce, R., Perrone, J., Abdelrahman, N., Sexton, J., Walcutt, J., Frisella, M.,
Matthews, B. 3 Surgical Innovation. 2009 Mar; 16(1): 46-54.
8 weeks
32 weeks
PGA
“120-Day Comparative Analysis of Adhesion Grade and
Quantity, Mesh Contraction, and Tissue Response to
a Novel Omega-3 Fatty Acid Bioresorbable Barrier
Macroporous Mesh After Intraperitoneal Placement”
Histology
1 week
16 weeks
Polypropylene
Mesh Type
N
Adhesion
Grade
(1-4)
Adhesion
Coverage
(%)
Mesh
Contraction
(%)
Sepramesh™
IP Composite
6
1.0 ± 0.0
0.0 ± 0.0
6.4 ± 8.4
ProLite Ultra
12
1.7 ± 1.1
10.7 ± 19.8
9.1 ± 8.3
C-Qur
6
1.2 ± 0.4
3.0 ± 7.3
3.3 ± 2.1
Composix
10
1.9 ± 1.2
24.8 ± 37.0
7.2 ± 7.1
Dualmesh
10
1.3 ± 0.9
1.4 ± 4.4
39.0 ± 6.0
Parietex
6
1.2 ± 0.4
0.8 ± 2.0
14.7 ± 5.0
Proceed
6
2.8 ± 1.0
28.8 ± 16.1
29.7 ± 12.5
7
2. Technical Data
B.
(cont.)
Ventralex™ Clinical Data1
Five Published Ventralex™ Studies
Study Author(s)
Tinella A et al. “Post-laparoscopic mesh in post-menopausal umbilical hernia repair:
a case series.” Minim Invasive Ther Allied Technol 2011.
Inversen E et al. “Abdominal wall hernia repair with a composite ePTFE/polypropylene mesh:
clinical outcome and quality of life in 152 patients.” Hernia 2010.
Vychnevskaia K et al. “Intraperitoneal mesh repair of small ventral abdominal wall
hernias with a Ventralex hernia patch.” Dig Surg 2010.
Martin et al. “Ventralex Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes
and Complications.” Hernia 2008.
Hadi H et al. “Intraperitoneal Tension-Free Repair of Small Midline Ventral Abdominal Wall
Hernias With a Ventralex Hernia Patch: Initial Experience in 51 Patients.” Hernia 2006.
Patients
Recurrence Rate Complication %
51
0.0%
0%
152
2.6%
11.8%
101
2.2%
1.9%
88
0%
2.2%
51
1.2%
5.8%
Clinical Summary1
“ Ventralex Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications”
(Hernia / 2008) D. F. Martin, R. F. Williams, T. Mulrooney, and G. R. Voeller 2
Overview:
• 88 patients (69 male, 19 female) were evaluated from 2003-2006 and
89 Ventralex™ Hernia Patches were placed.
• 0 hernia recurrences.
Background: This study is a retrospective review of all umbilical and
epigastric hernias repaired with the Ventralex hernia patch. Recent data
suggests that mesh repair of these hernias may decrease recurrent hernia
rates. Ideal placement of the mesh is behind the defect, which is difficult to
do without a large incision in these hernias unless done laparoscopically.
The Ventralex hernia patch is a composite PTFE/polypropylene patch
allowing intraperitoneal placement behind the hernia defect through a
small incision, and without the cost of laparoscopy.
Methods: Eighty-eight patients from 2003-2006 were evaluated and 89
Ventralex patches were used. The size of patches used were small (72%),
medium (27%), and unknown (1%). Average operating room time was 52
min (range 19-194). Follow-up visits ranged from 8 days to 3.1 years in all
but five patients.
Results: No hernia recurrences were found in follow-up. 93% of patients went home on the same day as
their surgery. Complications included two patients (2.2%) with mesh infection requiring removal of the
patch, one patient with post operative urinary retention, and seroma formation in another patient.
Conclusion: “The composite PTFE/polypropylene hernia patch is effective in preventing hernia recurrence in umbilical, epigastric, and small ventral hernia repairs and can be accomplished with a low rate
of complications.”
Ventralex™ clinical results may not directly correlate to Ventralex™ ST performance.
Dr. Voeller is a paid consultant to Davol Inc.
1
2
8
C.
Sepra® Technology Publications
The following selection of publications are provided for additional information on the use
of Sepra® Technology (ST). Sepra® Technology (ST) is an extensively studied hydrogel barrier,
used clinically since 2007.
Publications
#
Author
1
Pawlak M, Hilgers RD, Bury K,
Lehmann A, Owczuk R, Smietanski M
2
Title
Journal
Year
Comparison of two different concepts of mesh and fixation technique in
laparoscopic ventral hernia repair: a randomized controlled trial.
Surg. Endosc.
2015
Tollens T, Topal H, Lucardie A,
Vermeiren K, Aelvoet C
Long-term Outcome on the use of the Ventralight™ ST Hernia Patch in
Laparoscopic Ventral Hernia Repair.
Surg. Technol. Int.
2015
3
Tollens T, Vermeiren K, Topal H, and
Aelvoet C
Prospective Analysis of Laparoscopic Ventral Hernia Repair Using
the Ventralight™ ST Hernia Patch With or Without the Echo PS™
Positioning System.
Surg. Technol. Int.
2014
4
Tollens T, Topal H, Ovaere S, Beunis
A, Vermeiren K, Aelvoet C
Prospective analysis of ventral hernia repair using the Ventralight™ ST
Hernia Patch.
Surg. Technol. Int.
2013
5
Hanna EM, Voeller GR, Roth JS, Scott
JR, Gagne D, and Ianitti DA
Evaluation of Echo PS™ Positioning System in a Porcine Model of
Simulated Laparoscopic Ventral Hernia Repair.*
ISRN Surgery
2013
6
Deeken CR, Matthews BD
Ventralight™ ST and SorbaFix™ Versus Physiomesh™ and Securestrap™
in a Porcine Model.*
JSLS
2013
7
Sasse KC, Lim DC, and Brandt J
Long-term Durability and Comfort of Laparoscopic Ventral Hernia Repair. JSLS
2012
8
Deeken CR, Matthews BD
Comparison of Contracture, Adhesion, Tissue Ingrowth, and Histologic
Response Characteristics of Permanent and Absorbable Barrier Meshes in
a Porcine Model of Laparoscopic Ventral Hernia Repair.*
Hernia
2012
ACOS Meeting
2011
Note: Publications continued on to page 10.A Single-Arm, Single-Center, Retrospective Study with Prospective
9
Archer A, Fleischer S, Lohman R,
and Caldwell E
Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard®
Sepramesh™ IP Composite.
These articles are not intended to support or make any claims.
Please consult product labels and inserts for any indications, contradictions, hazards, warnings,
precautions and instructions for use.
* Data generated in a preclinical model. Data may not correlate to performance in humans.
Davol’s absorbable barrier products are intended for use in the reconstruction of soft tissue deficiencies,
such as for the repair of hernias.
9
2. Technical Data
C.
#
10
(cont.)
Sepra® Technology Publications (cont.)
Author
Gaertner WB, Bonsack ME,
Delaney JP
Title
Year
Visceral Adhesions to Hernia Prostheses.*
Hernia
2010
Pierce RA, Perronne JM, Nimeri A,
11 Sexton JA, Walcutt J, Frisella MM, and
Matthews BD
120-Day Comparative Analysis of Adhesion Grade and Quantity, Mesh
Contraction, and Tissue Response to a Novel Omega-3 Fatty Acid
Bioabsorbable Barrier Macroporous Mesh After Intraperitoneal Placement.*
Surg. Endosc.
2009
12 Eriksen, JR, Gögenur, I, Rosenberg, J
Choice of mesh for laparoscopic ventral hernia repair.*
Hernia
2007
Evaluation of New Prosthetic Meshes for Ventral Hernia Repair.*
J. Biomater. Appl
2006
13
Burger JW, Halm JA, Wijsmuller AR,
ten Raa S, and Jeekel J
These articles are not intended to support or make any claims.
Please consult product labels and inserts for any indications, contradictions, hazards, warnings,
precautions and instructions for use.
* Data generated in a preclinical model. Data may not correlate to performance in humans.
Davol’s absorbable barrier products are intended for use in the reconstruction of soft tissue deficiencies, such as
for the repair of hernias.
10
Journal
D.
Economic Value
How does Ventralex™ ST provide economic value?
According to published clinical data, the average OR cost is $83 per minute.* When minutes count, product choice matters.
Average OR time and costs savings with Ventralex™, versus retromuscular mesh repair†
Reference1
# Patients
Ventralextm
Surgery Time
Time Savings vs
Retromuscular Mesh
$ Savings
(time saved x $83)
Martin, 2008
88
52 min
28 min
$2,324
Iversen, 2010
152
39 min
41 min
$3,403
Vychnevskaia, 2010
101
33 min
47 min
$3,901
Berrevoet, 2011
60
34 min
46 min
$3,818
Hadi, 2006
51
30 min
50 min
$4,150
Average Procedure Cost: Retromuscular Mesh vs. Ventralex™
$8,000
$7,000
$6,632
Retromuscular Repair
Ventralex™
Procedure Cost
$6,000
$5,000
$4,316
$4,000
$3,237
$3,000
$2,822
$2,739
$2,490
$2,000
$1,000
0
Retromuscular
Repair†
Martin
2008
Iversen
2010
Berrevoet
2011
Vychnevskaia
2010
Hadi
2006
Reference
Shippert, R. “A Study of Time-Dependent Operating Room Fees and How to Save $100,000 by Using Time-Saving Products.”
The American Journal of Cosmetic Surgery (2005) Vol. 22, No. 1, 2005 Study cites $66/min, adjusted for inflation using the
US Department of Labor’s CPI Inflation Calculator.
†
79.9 minute mean operative retromuscular repair, as observed in Berrevoet F. et al “Open intraperitoneal versus retromuscular
mesh repair for umbilical hernias less than 3cm in diameter” The American Journal of Surgery (2011); 201: 85-90. 116 patients, 56 had a retromuscular repair.
1
Studies performed with Ventralex™ hernia patch.
*
11
3. Reimbursement
Reimbursements based on 2014 Medicare rates
DRG Classification
DRG Classification Dependent on Combination of
ICD-9 Procedure and ICD-9 Diagnostic Codes
(Inpatient Procedures)
353
Hernia procedures except inguinal & femoral w/ major
complications and comorbidities (MCC)
$14,975
354
Hernia procedures except inguinal & femoral w/ complications
and comorbidities (CC)
$8,807
355
Hernia procedures except inguinal & femoral w/o complications
of comorbidities (w/o CC or MCC)
$6,328
ICD-9 Procedure Codes
(Hospital Inpatient Procedures)
CPT Procedure Codes
(Physician, Hospital Outpatient,
Ambulatory Surgical Center)
Inpatient Hospital
Facility Payment
Umbilical Hernia (Open Approach)
53.41
Other and open repair of umbilical hernia with graft or prosthesis
53.42
Laparoscopic repair of umbilical hernia with graft or prosthesis
53.43
Other laparoscopic umbilical herniorrhaphy
53.49
Other open umbilical herniorrhaphy
Umbilical Hernia (Open Approach)
Physician
Payment In
Hospital
Outpatient
Hospital APC
Payment
49.585
Repair umbilical hernia, age 5
years or older; reducible
$452
$2,600
$1,436
49.587
Repair umbilical hernia, age 5
years or older; incarcerated or
strangulated
$484
$2,600
$1,436
49.652
Laparoscopy, surgical repair,
ventral, umbilical, spigelian or
epigastric hernia (includes mesh
insertion, when performed);
reducible
$700
$5,365
$2,964
49.653
Laparoscopy, surgical repair,
ventral, umbilical, spigelian or
epigastric hernia (includes mesh
insertion, when performed);
incarcerated or strangulated
$874
$5,365
$2,964
HCPCS Supply Code
Mesh
C1781
Mesh, implantable
This is not a comprehensive list of codes. Coding constantly changes so please reference the AMA and CMS websites
www.cms.gov; www.ama-assn.org and your local providers for additional information.
2014 National Average Medicare Rates.
12
Ambulatory
Surgery Center
Payment
4. Competitive Information
A.
Competitive Overview
Bard® Ventralex™ ST
Hernia Patch
Atrium® C-QUR™
V-Patch
Ethicon® Proceed
Ventral Patch
Covidien Parietex™
Ventral Patch
105 lbs of force
Not Available
Not Available
36 lbs of force
#1 umbilical patch sold in the market today1
Uncoated monofilament polypropylene for
rapid tissue ingrowth
SorbaFlex™ Memory Technology –
Absorbable Recoil Ring (PDO)
Recoil Ring encased in monofilament
polypropylene
Hydrogel barrier with over 10 publications
Proven technique supported by multiple
published, peer-reviewed clinical papers
Designed to fit down a trocar
Indicated for repair of trocar site deficiencies2
Average ball burst strength (n=10)3
B.
Cross Reference Chart
Ventralex™
Hernia Patch
Ventralex™ ST
Hernia Patch
C-QUR™
V-Patch
Proceed
Ventral Patch
Parietex™
Ventral Patch
Bard
Bard
Atrium
Ethicon
Covidien
Small Size
0010301
5950007
31200
PVPS
PCO4VP
Medium Size
0010302
5950008
31201
PVPM
PCO6VP
Large Size
0010303
5950009
31202
Not Available
PCO8VP
Manufacturer
Based on Q4 2013 IMS data.
As indicated in product IFU: Atrium C-QUR V-Patch (004677 Rev. 2011/01), Ethicon Proceed Ventral Patch (LAB-0012529, Rev 3), Covidien
Composite Ventral Patch (1306349)
3
3/8" burst probe. Bench data on file at C. R. Bard, Inc. Results may not correlate to performance in humans.
1
2
13
5. Material Management Information
A.
Packaging Overview
B.
Product Order Codes
Catalog Number
Quantity
5950007
1/cs.
Small Circle with Strap
1.7" x 1.7" (4.3 cm x 4.3 cm)
5950008
1/cs.
Medium Circle with Strap
2.5" x 2.5" (6.4 cm x 6.4 cm)
5950009
1/cs.
Large Circle with Strap
3.2" x 3.2" (8.0 cm x 8.0 cm)
C.
Shape
Bard® Steps to Successful Product Conversion*
Communicate
• Discussions with
OR and Materials
Managers
• VAC Product
Information Kit
presented
• Surgeon champions
confirmed
Educate
Evaluate and
Validate
Review
• Clinical Evaluation
Agreement signed
• Old product inventory
removed
• Meeting to review
results
• Evaluation posters
provided
• In-service of new
product begins
• Par levels set
• Stocking order placed
• Continuing education
of staff/shifts
• Product tables set up
• On-site rep support
during cases
• Preference cards
updated
• Future business review
meeting(s) scheduled
• Clinical validation
surveys
• Site support continues
• Nurse CE program
available
• Surgeon Hotline
(peer-to-peer)
14
Implement
• Introductory letter
distributed
• 24/7 medical services
and support
*
Size
Example of product introduction process. May vary by hospital facility.
6. Surgical Education
As a leader in soft tissue reconstruction, Bard Davol is committed to providing Education Programs
designed to help achieve your desired outcomes.
Your needs. Your schedule. Your peers.
Bard® Surgical Education Programs are designed to provide
you with focused and flexible modalities providing in-depth
education on products and techniques intended to help
optimize patient care.
Bard® Surgical Education courses cover many
advanced soft tissue repair techniques, including:
Surgeons who participate in the Bard® Surgical
Education Program benefit from:
• Ventral Repair
Hernia Repair
• Inguinal Repair
• Hiatal Repair
• Instruction from leading surgeon experts in state-ofthe-art minimally invasive and open surgical techniques
Complex Abdominal Wall Reconstruction
• Open Component Separation
• Opportunities to discuss and review surgical experience
with peers
• Endoscopic Component Separation
• Interactive exchanges with expert surgeons on specific
techniques
We are committed to advanced professional education –
providing new skills and approaches that help you provide
better outcomes to your patients.
• Opportunities to view live procedures
• Opportunities to practice these techniques through
hands-on Bioskills Labs
15
7. Value Added Programs
Committed to a Successful Partnership
Healthcare economics and new policies have changed the way you do business. It’s imperative to
work with a partner who understands your challenges, and who delivers both value and devices
that support best-in-class patient care. Bard partners benefit from highly personalized and valuable
services when they take advantage of full line of soft tissue repair products.
Access
As a Bard partner, one of your key benefits is receiving dedicated customer
service and personalized support. Whether it’s placing orders, answering billing
questions, finding cross-references or providing requested documentation, your
dedicated customer service specialist is on call for you.
Medical Services & Support
Medical Services & Support was created to assist you and your needs
as a medical provider in today’s changing healthcare environment. This
unique support team from Bard will provide you with technical and clinical
information on procedures involving Bard products and/or inquiries.
Our support staff consists of knowledgeable health professionals, including
surgeons, prepared to answer your questions and ready to meet your
resource needs.
Reimbursement Hotline
Davol’s Reimbursement Hotline is dedicated to providing answers to all your
reimbursement questions. It also serves as a resource for obtaining accurate
billing information and reimbursement support for Bard products. Help is provided for the following topics: Reimbursement Codes, Reimbursement Assistance, Predetermination/Precertification, Denials and Appeals.
Resources
As a Bard partner, you can take advantage of cutting-edge iPhone and iPad
apps for your team members. They provide instant access to Bard product
information, including surgical technique guides, surgical videos, product ordering
information, instructions for use and more.
Patient Support
In addition, we can provide a hernia consultation app along with customized
brochures on hernia repair to help your surgeons educate their patients.
Contact your local Davol representative for more information.
16
Bard is the market leader in comprehensive soft tissue reconstruction, delivering a growing line
of mesh prosthetics, biologic implants and fixation systems to complement innovative techniques
for inguinal, ventral and other hernia repair procedures. In addition to this extensive suite of
products, our Biosurgery franchise is delivering a growing line of enhanced sealants and hemostatic
products to complement surgical techniques across thoracic, cardiovascular and other surgical
specialties. Our researchers are constantly engaged in expanding the range of soft tissue repair
with products aimed at providing exceptional reliability and value – qualities that clinicians,
physicians and patients have come to depend on.
Right Product.
Right Procedure.
For more information, visit www.davol.com
Please consult product labels and inserts for any indications, contraindications, hazards,
warnings, precautions and instructions for use.
Bard, Davol and Ventralex are trademarks and/or registered trademarks of C. R. Bard, Inc.
All other trademarks are the property of their respective owners.
© Copyright 2015, C. R. Bard, Inc. All Rights Reserved. DAV/VXST/0814/0010(1)
Davol Inc. • Subsidiary of C. R. Bard, Inc.
100 Crossings Boulevard • Warwick, RI 02886
1.800.556.6275 • www.davol.com
Medical Services & Support 1.800.562.0027
Right Outcome.