A Bard® System for Laparoscopic Ventral Hernia Repair. Unique design. Exceptional performance. Proven results.

A comprehensive review of bench testing, preclinical and clinical data.

Ventralight™ ST Mesh

SorbaFix™ Absorbable Fixation System

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.

Success is in our system. Ventralight™ ST Absorbable Barrier Mesh and the SorbaFix™ Absorbable Fixation System. Mesh and Fastener Design: • Lightweight low profile mesh design which facilitates trocar deployment. • Consistent thread diameter from head to tip for maximum tissue engagement.

System Success Supported by Clinical Data Dr. Andrew Archer completed the 1st human clinical study on Sepramesh™ IP Composite including SorbaFix™ Absorbable Fixation System.

Initial implant*

Strength of Tissue Ingrowth In A Preclinical Study1 1.2

Strong Tissue Ingrowth:

Mean Force (lbs.)

1.0

• Bare monofilament polypropylene allows for fast tissue ingrowth and a strong, long-term repair.

0.8 0.6 0.4

• Hollow core fastener design allows tissue ingrowth through interior of fastener.*

0.2 0 0 2 4 6 8 10 12 Week

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.*

Minimizes Tissue Attachment: • Based on the technology used in Seprafilm.™ • Swells to minimize tissue attachment to the visceral side of the mesh.* • Smooth flat head of SorbaFix™ fastener may reduce adhesion development and tenacity.2*

Ventralight™ ST Mesh has the same absorbable barrier as Sepramesh™ IP Composite, but with a lightweight polypropylene mesh. •

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. September 2011 ACOS Meeting. Andrew Archer, DO, Stephen Fleischer, DO, Rhett Lohman, DO, Edward Caldwell, DO. ACOS. Grandview Medical Center, Dept. of Surgery, Dayton, OH.

2 weeks*

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. 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. 1

Proof is in our data. At Bard, we believe success is measured in every step of the repair. We utilize proven materials, designed to work together, along with proven surgical techniques. Our goal is to help you achieve a strong, long-term repair for you and your patients. As part of our ongoing committment to share data, we have undertaken a comprehensive preclinical study, along with bench testing, to demonstrate the differences and advantages that the Bard® system of Ventralight™ ST Absorbable Barrier Mesh and SorbaFix™ Absorbable Fixation System presents when compared to the Ethicon® system of Physiomesh™ and SecureStrap.™

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Mesh Findings Innovative Mesh Construction: Open pore design and unique hydrogel barrier Ventralight™ ST

Physiomesh™ Monocryl* (poliglecaprone 25) Suture polymer PDS (polydioxanone) suture polymer Strong thin filament, macroporous mesh

Bare monofilament polypropylene

Hydrogel barrier swells to minimize attachment and resorbs within 30 days

Bioresorbable PGA fibers reinforce the integrity of the hydrogel barrier by binding it to the polypropylene

PDS Suture polymer Monocryl* (poliglecaprone 25) Suture polymer

• Sepra® Technology has over 14 years of proven clinical success.

• As of Mar 2012, no peer reviewed clinical or preclinical published data available on Monocryl’s effectiveness as a barrier.

• Publication references on back page.

* Per Ethicon brochure PHYSM-232-10-6/12

Allows for fast tissue ingrowth: For a strong, long-term repair Ventralight™ ST

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

Physiomesh™

**

-86% *

1.50

Mesh

T-Peel Force (N/cm)

1.25

Ventralight™ ST Mesh demonstrated 37% greater tissue ingrowth compared to lateral sections of Physiomesh™ and 86% greater tissue ingrowth than the Physiomesh™ center point, marked by its PDS orientation marker.1

1.00

-37% BARD® SORBAFIX™ Absorbable Fixation System

VENTRALIGHT™ ST Mesh

**

-78% Physiomesh (mesh)

™

0.75 0.50 0.25

Physiomesh™ (PDS Marker)

0.00

Mean SEM; *P ± < 0.01; ** P < 0.0001

BARD® Internal Test

1.75

ETHICON Physiomesh™ (mesh)

Mesh

ETHICON

™ The Physiomesh point, marked by Physiomeshcenter (FDO market) its PDS orientation marker, demonstrated 78% less ingrowth than lateral sections of Physiomesh.™1 ™

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 1 2

Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans. 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.

Fixation Findings SorbaFix™ Unique Fastener Construction: No sharp fasteners left behind

SorbaFix™

BLUNT FASTENER ATRAUMATIC TIP

YES

NO

5.9 mm

4.9 mm Tissue Grip

Retracting Piloting Tip

Sharp Piloting Strap

NO

YES

YES**

NO**†

DEPTH OF TISSUE PURCHASE* DELIVERY METHOD SHARP FASTENER LEFT BEHIND IN PATIENT REMOVABLE FASTENER

SecureStrap™

* 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.

Secure Fixation at Angles: A significant difference at 45° Bench Testing Results

SorbaFix™ with Ventralight™ ST vs. SecureStrap™ with Physiomesh™ All tacks were delivered using a clinically relevant opposition force for SorbaFix™ as per the SorbaFix™ instructions for use and for SecureStrap™ as per the SecureStrap™ instructions for use.

• The SorbaFix™ fastener average shear force is 43% higher than the SecureStrap™ when deployed at a 45° angle (p < 0.006).

Average Strength of Tacks Delivered at 45° & 90° 3.50

Shear Holding Force (lbf)

3.00

BARD® SORBAFIX™ BARD® SORBAFIX™

2.50 2.00

• At 90°, there is no statistical difference between the devices.

ETHICON SecureStrap™

ETHICON SecureStrap™

BARD® SORBAFIX™ Absorbable Fixation System (n=30)

1.50 1.00 Ethicon SecureStrap™ (n=30)

0.50 0.00

45 Degrees

90 Degrees

Clinically Relevant Opposition Force: Put control back in your hands — at any angle.

Fastener Findings* Ventralight™ ST and SorbaFix™

Physiomesh™ and SecureStrap™

• Fastener site hemorrhage occured with SecureStrap™ fasteners 14% of the time vs. 0.7% with SorbaFix.™† • The unique design of the SorbaFix™ fastener allows it to be removed to address hemostasis vs. the design of the SecureStrap™ which does not allow for removal.†† † ††

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.

Results* Representative preclincal results via laparoscopic viewing at day 14. Ventralight™ ST and SorbaFix™

Physiomesh™ and SecureStrap™

Uniform Integration

Irregular Integration

• Ventralight™ ST Mesh/SorbaFix™ Absorbable Fixation System demonstrated uniform anterior surface tissue integration and visceral surface reperitonealization, whereas Physiomesh™/SecureStrap™ demonstrated delayed/irregular anterior surface tissue integration and irregular visceral surface reperitonealization. • Serous fluid was also observed between the anterior mesh surface of the abdominal wall with Physiomesh™/SecureStrap.™

Bard Ventralight™ ST and SorbaFix™ Absorbable Fixation System. Unique design. Exceptional performance. Proven results. For more information, call 1.800.556.6275 and speak to a representative. Or visit www.davol.com/LapVentSystem. * Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.

The proof is in OUR data. We’ll be glad to furnish you copies of the folowing publications. 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.

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.*

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.

Echo PS ™ Positioning System comes pre-attached to Ventralight ™ ST Mesh

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.

For more information, call 1.800.556.6275 and speak to a representative. Or visit www.davol.com/LapVentSystem.

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.

* System designed to eliminate the time and effort involved with placing and pulling up of orientation sutures.

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

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