Advancing the Open Ventral Hernia Repair Experience · during open ventral hernia repair. Hernia...

SOFT TISSUE REPAIRRight Procedure. Right Product. Right Outcome.

Advancing the Open Ventral Hernia Repair Experience

Optimized Design for Open Ventral Hernia Repair The OptiFix™ Open Absorbable Fixation System was designed for improved ease of use when

fixating surgical meshes to the abdominal wall in open ventral hernia procedures by reducing

limitations that exist with current laparoscopic straight devices. Combined with Ventrio™ ST,

it provides a full system for open ventral hernia repair.

Optimized Handle facilitates comfortable and easy firing of the device during open ventral hernia repair.

Hernia Repair Fixation

Ergonomic Handle Contoured to fit a wide variety of surgeon hand sizes1

Inverted Handle and Trigger Designed to improve hand placement in open ventral hernia repairs2

1 Survey of surgeons attending preclinical lab. Results may not correlate to clinical outcomes. Data on file.2 Survey of surgeons attending market research initiative. Results may not correlate to clinical outcomes. Data on file.

Absorbable Fixation System

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Outcome-driven fixationThe OptiFix™ Open Absorbable Fastener is made from Poly(D, L-Lactide) and is designed for optimal performance. Fastener features include:

Smooth Fastener Head

• Minimizes the potential for tissue attachment3

• Ensures mesh is securely fixated

Hollow Core Design

• Allows tissue ingrowth through the fastener3

Angled Tip

• Easily penetrates mesh and tissue

Stabilizers

• Enhances tissue holding strength

• Prevents the fastener from backing out

Metric Scale Aids in mesh overlap measurements

27 cm Cannula Length• Designed to improve ergonomics and access in open

ventral hernia procedures and pocketed mesh1,2

• Shortens the distance between the surgeon and mesh in an open ventral hernia procedure

Curved Cannula Designed to: - Consistently deliver fasteners

perpendicular to mesh and tissue4

- Improve positioning and handling

Smooth TipHelps to improve tip insertion into pocketed mesh1

1 Survey of surgeons attending preclinical lab. Results may not correlate to clinical outcomes. Data on file.2 Survey of surgeons attending market research initiative. Results may not correlate to clinical outcomes. Data on file. 3 Preclinical data on file. Results may not correlate to clinical outcomes. 4 C. R. Bard, Inc. bench data on file. Results may not correlate to clinical outcomes.

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Enlargement

3 Preclinical data on file. Results may not correlate to clinical outcomes.

4 C. R. Bard Inc., bench data on file. Results may not correlate to clinical outcomes.

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AbsorbaTack™ 8.6 mm2

OptiFix™ 9.0 mm2

SecureStrap™ 1.8 mm2

Broader fastener surface area coverage results in more secure mesh fixation and more visible fasteners.4

5X magnification4

Fastener and Mesh Retention Surface Area and Visibility

Point of Tissue Penetration Comparison

4.3 mm tissue grip

5.3 mm tissue purchase 3.5 mm tissue purchase

Ventralight™ ST Mesh 0.6 mm mesh thickness

AbsorbaTack™

SecureStrap™OptiFix™

The OptiFix™ Open fastener is designed to deliver strong mesh retention by providing 5.3 mm tissue

depth of purchase, more mesh retention surface area coverage than AbsorbaTack™ and SecureStrap™

fasteners, and a hollow core that allows for tissue ingrowth.3 Designed with the patient in mind, the fas-

tener also slowly resorbs over time leaving less foreign material behind.4

A Strong Repair with the Patient in Mind

OptiFix™ Open fasteners provide secure fixation during the postoperative healing period then slowly resorb over time

Strength Retention Over Time4

Burst Pressure Over Time in a Porcine Model3

Weeks Post Implantation

Weeks Post Implantation

Burst Pressure

(N)

Maximum Intraabdominal PressureBurst Pressure

0

20%

40%

60%

80%

100%

120%

T= 0 8 weeks 32 weeks

0

50

100

300

350

150

200

250

T=0 4 weeks2 weeks 8 weeks

After 8 weeks maintains burst pressure at approximately 7x the max IAPDue to fastener holding strength and aggressive tissue ingrowth through the hollow core.

OptiFix™ Open fasteners maintain strength through the crucial healing period, then begin to resorb.

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4 C. R. Bard Inc., bench data on file. Results may not correlate to clinical outcomes.

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5 Iannitti, D. et al. “Technique and Outcomes of Abdominal Incisional Hernia Repair Using a Synthetic Composite Mesh: A Report of 455 cases.” Journal of the American College of Surgeons. 2008 Jan; 206 (1):83-8.

Easy • Provides the benefits of a laparoscopic repair through the ease of

a smaller incision

• SorbaFlex™ Memory Technology allows the patch to lay flat to maintain shape and then fully rebsorbs over time3

• Simplifies placement and positioning of the patch throughout the ventral hernia repair

Efficient• Designed to facilitate the use of mechanical fixation devices and/or sutures

• Unique pocket aids in the proper placement and positioning of the patch

• Available in a variety of shapes and sizes to accommodate defect sizes and locations

Proven• Hydrogel barrier is based on Sepra® Technology

• Uncoated monofilament polypropylene mesh allows for complete tissue ingrowth leading to a strong repair

• Materials have been used in general surgery for years with demonstrated clinical success5

A Complete Open Ventral Hernia Repair Solution

OptiFix™ Open Absorbable Fixation SystemIndications The OptiFix™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair.

Contraindications 1. Contraindications associated with open surgical procedures relative to mesh fixation apply, including but not limited to:

• Fixation of vascular or neural structures

• Fixation of bone and cartilage

• Situations with insufficient ingrowth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is absorbed.

2. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera or bone. Use of the OptiFix™ Open Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 6.1 mm, the fastener head is another 0.6 mm (total 6.7 mm).

Warnings The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use. After use, the OptiFix™ Open Absorbable Fixation System may be a potential biohazard. Handle and dispose of in accordance with any local and federal laws regarding medical waste.

Adverse Reactions Adverse reactions and potential complications associated with fixation devices such as the OptiFix™ Open 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; infection/septicemia; hernia recurrence/wound dehiscence.

VentriO™ ST Hernia Patch

Indications The Ventrio ST™ Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias

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Contraindications Do not use the Ventrio™ ST Hernia Patch in infants or children, whereby future growth will be compromised by the use of such mesh material. Do not use the Ventrio™ ST Hernia Patch for the reconstruction of cardiovascular defects. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.

Warnings Do not cut or reshape the Ventrio™ ST Hernia Patch, as this could impact its effectiveness. Care should be taken not to cut or nick the SorbaFlex™ PDO monofilament during insertion or fixation. If the SorbaFlex™ PDO monofilament is cut or damaged, additional complications may include bowel or skin perforation and infection. Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may compromise the SorbaFlex™ PDO monofilament. Ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh side against the bowel. There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera.

Adverse Reactions Possible complications include seroma, adhesions, hematomas, 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 insertion or fixation, additional complications may include bowel or skin perforation and infection.

OptiFix™ Open Absorbable Fixation SystemCatalog Number Configuration Qty

0113320 20 Absorbable Fasteners 5/case

Ventrio™ ST Hernia PatchCatalog Number Shape Mesh Size Qty

5950030 Small Oval 3.1" x 4.7" (8.0 cm x 12.0 cm) 1/cs.

5950040 Medium Oval 4.3" x 5.5" (11.0 cm x 14.0 cm) 1/cs.

5950050 Large Oval 5.4" x 7.0" (13.8 cm x 17.8 cm) 1/cs.

5950010 Small Circle 3.0" (7.6 cm) diameter 1/cs.

5950020 Large Circle 4.5" (11.4 cm) diameter 1/cs.

5950070 Extra Large Oval 7.7" x 9.7" (19.6 cm x 24.6 cm) 1/cs.



5950060 Midline 6.1" x 10.1" (15.5 cm x 25.7 cm) 1/cs.

Ventralex™ STCatalog Number Shape Mesh Size Qty

5950007 Small Circle with Strap 1.7" (4.3 cm) diameter 1/cs.

5950008 Medium Circle with Strap 2.5" (6.4 cm) diameter 1/cs.

5950009 Large Circle with Strap 3.2" (8.0 cm) diamter 1/cs.

To learn more, contact your local Bard Representative or call 1.800.556.6275.

Davol Inc. • Subsidiary of C. R. Bard, Inc.100 Crossings Boulevard • Warwick, RI 028861.800.556.6275 • www.davol.com Medical Services & Support 1.800.562.0027DAV/OPOP/0317/0004

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.

Bard, Davol, OptiFix, SorbaFlex, Ventralex and Ventrio are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. All other trademarks are the property of their respective owners.© Copyright 2017, C. R. Bard, Inc. All Rights Reserved.

Absorbable Fixation System

Ventralex™

Catalog Number Shape Mesh Size Qty

0010301 Small Circle with Strap 1.7" (4.3 cm) diameter 2/cs.

0010302 Medium Circle with Strap 2.5" (6.4 cm) diameter 2/cs.

0010303 Large Circle with Strap 3.2" (8.0 cm) diameter 2/cs.Ventrio™ Hernia Patch

Catalog Number Shape Mesh Size Qty

0010211 Small Oval with EPTFE

3.1" x 4.7" (8.0 cm x 12.0 cm) 1/cs.

0010212 Large Oval with EPTFE

5.4" x 7.0" (13.8 cm x 17.8 cm) 1/cs.

0010213 Small Circle with EPTFE

3.0" (7.6 cm) diameter 1/cs.

0010214 Large Circle with EPTFE

4.5" (11.4 cm) diameter 1/cs.

0010215 Medium Oval with EPTFE

4.3" x 5.5" (11.0 cm x 14cm) 1/cs.

0010216 Extra Large Oval with EPTFE

8.7" x 10.7" (22.1 cm x 27.1 cm) 1/cs.


10.8" x 13.7" (27.4 cm x 34.9 cm) 1/cs.


7.7" x 9.7" (19.6 cm x 24.6 cm) 1/cs.

0010219 Oval with EPTFE 6.3" x 12.3" (16.0 cm x 31.2 cm) 1/cs.

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Advancing the Open Ventral Hernia Repair Experience · during open ventral hernia repair. Hernia...

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