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.