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Ventralight™ ST Mesh
A comprehensive review of bench testing, preclinical and clinical data.
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction and recurrence of the hernia or soft tissue defect. Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to, the following: hemorrhage, pain, edema, and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence. Care should be given to underlying structures such as nerves, vessels, viscera or bone. Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
A Bard® System for Laparoscopic Ventral Hernia Repair.Unique design. Exceptional performance. Proven results.
SorbaFix™ Absorbable Fixation System
Mesh and Fastener Design:• Lightweightlowprofilemeshdesign
whichfacilitatestrocardeployment.
• Consistentthreaddiameterfromheadtotipformaximumtissueengagement.
Initial implant*
System Success Supported by Clinical DataDr. Andrew Archer completed the 1st human clinical study on Sepramesh™ IP Composite including SorbaFix™ Absorbable Fixation System.
Ventralight™ STMeshhasthesameabsorbablebarrierasSepramesh™ IP Composite,butwithalightweightpolypropylenemesh.
• 90 patients
• 3 year mean follow-up
• Recurrence rate of 1.1%
• Low rates of short-term and long-term complications
A Single-Arm, Single-Center, Retrospective Study with Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard® Sepramesh™ IP Composite.September2011ACOSMeeting.AndrewArcher,DO,StephenFleischer,DO,RhettLohman,DO,EdwardCaldwell,DO.ACOS.GrandviewMedicalCenter,Dept.ofSurgery,Dayton,OH.
Success is in our system.Ventralight™ ST Absorbable Barrier Mesh and the SorbaFix™ Absorbable Fixation System.
Proof is in our data.AtBard,webelievesuccessismeasuredineverystepoftherepair.Weutilizeprovenmaterials,designedtoworktogether,alongwithprovensurgicaltechniques.Ourgoalistohelpyouachieveastrong,long-termrepairforyouandyourpatients.
Aspartofourongoingcommittmenttosharedata,wehaveundertakenacomprehensivepreclinicalstudy,alongwithbenchtesting,todemonstratethedifferencesandadvantagesthattheBard®systemofVentralight™STAbsorbableBarrierMeshandSorbaFix™AbsorbableFixationSystempresentswhencomparedtotheEthicon®systemofPhysiomesh™andSecureStrap.™
Ventralight™ ST and SorbaFix™ devices work together to deliver strong tissue ingrowth throughout the critical first two week post-operative time frame. Then this unique system continues to create a strong, long-term repair.
1 Majercik, S. et al. “Strength of tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surgical Endoscopy (2006) 20: 1671-1674.2 N Agee MD, KN Lau MD, JJ Heath BS, HJ Norton PhD, AE Lincourt PhD, JB Martinie MD, DA Iannitti MD “Mesh Fixation: Evaluation of a Novel Permanent and Absorbable Construct Design. Hernia, May 2011. * Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.
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.*
Strength of Tissue Ingrowth In A Preclinical Study1
1.2
1.0
0.8
0.6
0.4
0.2
0
0 2 4 6 8 10 12
Mea
n Fo
rce
(lbs
.)
Week
Strong Tissue Ingrowth: • Baremonofilamentpolypropylene
allowsforfasttissueingrowthandastrong,long-termrepair.
• Hollowcorefastenerdesignallowstissueingrowththroughinterioroffastener.*
2 weeks*
Minimizes Tissue Attachment:• BasedonthetechnologyusedinSeprafilm.™
• Swellstominimizetissueattachmenttothevisceralsideofthemesh.*
• SmoothflatheadofSorbaFix™fastenermayreduceadhesiondevelopmentandtenacity.2*
å
1 Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans. 2 Majercik, S. et al. “Strength in tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surgical Endoscopy (2006) 20: 1671-1674.
* Per Ethicon brochure PHYSM-232-10-6/12
Allows for fast tissue ingrowth: For a strong, long-term repair
Uncoated polypropylene allows for the majority of tissue ingrowth and strength to occur in the first two weeks after placement of a composite hernia prosthesis.2
Mesh Findings
• Sepra®Technologyhasover14yearsofprovenclinicalsuccess.
• Publication references on back page.
• AsofMar2012,nopeerreviewedclinicalorpreclinicalpublisheddataavailableonMonocryl’seffectivenessasabarrier.
Innovative Mesh Construction: Open pore design and unique hydrogel barrier
Ventralight™ ST Physiomesh™
PDS Suture polymer
PDS (polydioxanone) suture polymer
Monocryl* (poliglecaprone 25) Suture polymer
Monocryl* (poliglecaprone 25) Suture polymer
Strong thin filament, macroporous mesh
Bare monofilament polypropylene
Bioresorbable PGA fibers reinforce the
integrity of the hydrogel barrier by binding it to
the polypropylene
Hydrogel barrier swells to minimize attachment and
resorbs within 30 days
BARD® SORBAFIX™ Absorbable Fixation System
ETHICON Physiomesh™ (mesh)
ETHICON Physiomesh™ (FDO market)
T-Pe
el F
orce
(N
/cm
)
1.25
1.00
0.75
0.25
0.50
0.00
1.75
1.50
BA
RD
® In
tern
al T
est
Mean SEM; *P ± < 0.01; ** P < 0.0001
VENTRALIGHT™ ST Mesh
Physiomesh™
(mesh)
Physiomesh™
(PDS Marker)
-86%**
-78%**
-37%*
Preclinical Study T-Peel Force Testing to Measure Anterior Tissue Ingrowth (n = 10 per system)
Bard® Ventralight™ ST Mesh /SorbaFix™ Absorbable Fixation System vs. Ethicon Physiomesh™/SecureStrap™ via porcine model
Ventralight™STMeshdemonstrated37%greatertissueingrowthcomparedtolateralsectionsofPhysiomesh™and86%greatertissueingrowththanthePhysiomesh™centerpoint,markedbyitsPDSorientationmarker.1
ThePhysiomesh™centerpoint,markedbyitsPDSorientationmarker,demonstrated78%lessingrowththanlateralsectionsofPhysiomesh.™1
Physiomesh™Ventralight™ ST
Mesh
Mesh
Secure Fixation at Angles: A significant difference at 45°
Bench Testing Results
SorbaFix™ with Ventralight™ ST vs. SecureStrap™ with Physiomesh™
AlltacksweredeliveredusingaclinicallyrelevantoppositionforceforSorbaFix™aspertheSorbaFix™instructionsforuseandforSecureStrap™aspertheSecureStrap™instructionsforuse.
Clinically Relevant Opposition Force: Put control back in your hands — at any angle.
* Depth of purchase does not include thickness of prosthetic. ** Per individual products' instructions for use. Ethicon SecureStrap™ IFU#389901R01. † If necessary, the straps may be dislodged from the mesh by cutting the strap with a laparoscopic scissor.
Pull the mesh away from the strap and leave the strap in the tissue to resorb.
Average Strength of Tacks Delivered at 45° & 90°
BARD® SORBAFIX™ Absorbable Fixation System (n=30)
Ethicon SecureStrap™
(n=30)
Shea
r H
oldi
ng F
orce
(lb
f) 2.50
2.00
1.50
0.50
1.00
0.00
3.50
3.00
90 Degrees45 Degrees
ETHICON SecureStrap™
ETHICON SecureStrap™
BARD® SORBAFIX™
BARD® SORBAFIX™
• TheSorbaFix™fasteneraverageshearforceis43%higherthantheSecureStrap™whendeployedata45°angle(p < 0.006).
• At90°,thereisnostatisticaldifferencebetweenthedevices.
SorbaFix™ Unique Fastener Construction: No sharp fasteners left behind
BLUNT FASTENER ATRAUMATIC TIP YES NO
DEPTH OF TISSUE PURCHASE* 5.9 mm 4.9 mm Tissue Grip
DELIVERY METHOD Retracting Piloting Tip Sharp Piloting Strap
SHARP FASTENER LEFT BEHIND IN PATIENT NO YES
REMOVABLE FASTENER YES** NO**†
SecureStrap™SorbaFix™
Fixation Findings
* Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.
Fastener Findings*
• FastenersitehemorrhageoccuredwithSecureStrap™fasteners 14%ofthetimevs. 0.7%withSorbaFix.™†
• TheuniquedesignoftheSorbaFix™fastenerallowsittoberemovedtoaddresshemostasisvs.thedesignoftheSecureStrap™whichdoesnotallowforremoval.††
Ventralight™ ST and SorbaFix™ Physiomesh™ and SecureStrap™
For more information, call 1.800.556.6275 and speak to a representative. Or visit www.davol.com/LapVentSystem.
Bard Ventralight™ ST and SorbaFix™ Absorbable Fixation System. Unique design. Exceptional performance. Proven results.
Results*
• Ventralight™STMesh/SorbaFix™AbsorbableFixationSystemdemonstrateduniformanteriorsurfacetissueintegrationandvisceralsurfacereperitonealization,whereasPhysiomesh™/SecureStrap™demonstrateddelayed/irregularanteriorsurfacetissueintegrationandirregularvisceralsurfacereperitonealization.
• SerousfluidwasalsoobservedbetweentheanteriormeshsurfaceoftheabdominalwallwithPhysiomesh™/SecureStrap.™
Physiomesh™ and SecureStrap™Ventralight™ ST and SorbaFix™
Uniform Integration Irregular Integration
Representative preclincal results via laparoscopic viewing at day 14.
† Percentages were calculated based on the number of fasteners used for each implanted mesh per system, n=10.† † Per individual products' instructions for use. Ethicon SecureStrap™ IFU#389901R01.
Davol Inc. • Subsidiary of C. R. Bard, Inc.100 Crossings Boulevard • Warwick, RI 02886
1.800.556.6275 • www.davol.comMedical Services & Support 1.800.562.0027
Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
Bard, Davol, Echo PS, SorbaFix and Ventralight are trademarks and/or registered trademarks of C. R. Bard, Inc., Sepra, Seprafilm and Sepramesh are registered trademarks of Genzyme Corporation licensed to C. R. Bard, Inc. All other trademarks are the property of their respective owners.
© Copyright 2012, C. R. Bard, Inc. All Rights Reserved.
MMVSYS1
The proof is in OUR data. We’ll be glad to furnish you copies of the folowing publications.
* System designed to eliminate the time and effort involved with placing and pulling up of orientation sutures.
Echo PS™ Positioning System comes pre-attached to
VEntralight™ ST Mesh
Echo PS™ Positioning System: Another part of the innovative Bard laparoscopic ventral hernia repair solution Helps ensure consistent, effective results with its mesh positioning technology and time-saving technique.*
For more information, call 1.800.556.6275 and speak to a representative. Or visit www.davol.com/LapVentSystem.
Sepra® Technology
Archer, Andrew, DO., et al. A Single-Arm, Single-Center, Retrospective Study with Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh™ IP Composite. September 2011 ACOS Meeting.
Becker, James M, FACS., et al. Prevention of Postoperative Abdominal Adhesions by a Sodium Hyaluronate-Based Bioresorbable Membrane: A Prospective, Randomized, Double-Blind Multicenter Study. Journal of the American College of Surgeons (1996) Vol. 183, No. 4: 297-306.
Fazio, Victor W, MB, MS., et al. Reduction in Adhesive Small-Bowel Obstruction by Seprafilm* Adhesion Barrier after Intestinal Resection. Diseases of the Colon & Rectum (2005) 49: 1-11.
Vrijland, Wietske W, MD., et al. Fewer Intraperitoneal Adhesions with Use of Hyaluronic Acid-Carboxymethylcellulose Membrane: A Randomized Clinical Trial. Annals of Surgery (2002) Vol. 235, No. 2: 193-199.
Pierce, Richard A, MD, PhD., et al. 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. Surgical Innovation March 2009: 16,1:46-54.
Burger, J.W.A., et al. Evaluation of New Prosthetic Meshes for Ventral Hernia Repair. Surgical Endoscopy 2006:20:1320-1325.
van't Riet, Martijne van’t, MD., et al. Prevention of Adhesion to Prosthetic Mesh — Comparison of Different Barriers Using an Incisional Hernia Model. Annals of Surgery January 2003:237:123-128.
Borrazzo, E.C., et al. Effect of Prosthetic Material on Adhesion Formation after Laparoscopic Ventral Hernia Repair in A Porcine Model. Hernia 2004:8:108-112.
Leber, G.E., et al. Long-Term Complications Associated with Prosthetic Repair of Incisional Hernias. Arch Surg 1998; 133:378-382.
Amid, P.K., et al. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archiv fur Chirurgie 1994:379:168-171.
Klosterhalfen, B., et al. Polymers in Hernia Repair – Common Polyester vs. Polypropylene Surgical Meshes. Journal of Materials Science 35 (2000): 4769-4776.
Khan, L. R., et al. Early Results for New Lightweight Mesh in Laparoscopic Totally Extra-Peritoneal Inguinal Hernia Repair. Hernia (2006)10:303-308.
Scott, Jeffrey R, PhD., et al. Ventralex™ ST Hernia Patch: Characterization of Adhesion, Contracture and Histological Properties Following In Vivo Implantation, as Compared to an Oxidized Regenerated Cellulose Barrier Device in a Porcine Model. Bard, Inc. – Davol, Warwick, RI.
Deeken, Corey R, PhD., et al. Comparison of Adhesion and Contracture Characteristics of Permanent and Absorbable Barrier Mesh Products Following Implantation/Fixation with Mechanical Absorbable Fixation in a Porcine Model of Simulated Laparoscopic Ventral Hernia Repair. Presented at the 19th SLS Annual Meeting in September 2010. Washington University School of Medicine. Department of Surgery St. Louis, Missouri, USA.
SorbaFix™ Absorbable Fixation
Gillian, Kevin G, MD, FACS., et al. Burst Strength of Ventral Hernia Repairs in a Chronic Porcine Model: Comparison of Repairs Fixated with the SorbaFix™ Fixation System to Those Using Permanent Fixation.
Byrd, J.F., et al. Evaluation of Absorbable and Permanent Mesh Fixation Devices: Adhesion Formation and Mechanical Strength. Hernia DOI 10.1007/s10029-011-0826-9.
Archer, Andrew, DO., et al. A Single-Arm, Single-Center, Retrospective Study with Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh™ IP Composite. September 2011 ACOS Meeting. Grandview Medical Center, Department of Surgery, Dayton, OH.