Advancing the Open Ventral Hernia Repair Experience

Transcription

1 Advancing the Open Ventral Hernia Repair Experience SOFT TISSUE REPAIR Right Procedure. Right Product. Right Outcome.

2 Hernia Repair Fixation Absorbable Fixation System 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. Ergonomic Handle Contoured to fit a wide variety of surgeon hand sizes 1 Inverted Handle and Trigger Designed to improve hand placement in open ventral hernia repairs 2 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. 2

3 Outcome-driven fixation The 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 attachment 3 Ensures mesh is securely fixated Enlargement Hollow Core Design Allows tissue ingrowth through the fastener 3 Angled Tip Easily penetrates mesh and tissue Stabilizers Enhances tissue holding strength Prevents the fastener from backing out 27 cm Cannula Length Designed to improve ergonomics and access in open ventral hernia procedures and pocketed mesh 1,2 Shortens the distance between the surgeon and mesh in an open ventral hernia procedure Smooth Tip Helps to improve tip insertion into pocketed mesh 1 Metric Scale Aids in mesh overlap measurements Curved Cannula Designed to: -- Consistently deliver fasteners perpendicular to mesh and tissue 4 -- Improve positioning and handling 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. 3

4 A Strong Repair with the Patient in Mind 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 fastener also slowly resorbs over time leaving less foreign material behind. 4 Fastener and Mesh Retention Surface Area and Visibility 5X magnification 4 OptiFix 9.0 mm 2 AbsorbaTack 8.6 mm 2 SecureStrap 1.8 mm 2 Broader fastener surface area coverage results in more secure mesh fixation and more visible fasteners. 4 Point of Tissue Penetration Comparison 5.3 mm tissue purchase 4.3 mm 3.5 mm tissue grip tissue purchase Ventralight ST Mesh 0.6 mm mesh thickness OptiFix SecureStrap AbsorbaTack 4 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.

5 OptiFix Open fasteners provide secure fixation during the postoperative healing period then slowly resorb over time Strength Retention Over Time 4 120% 100% 80% 60% OptiFix Open fasteners maintain strength through the crucial healing period, then begin to resorb. 40% 20% 0 T= 0 8 weeks 32 weeks Weeks Post Implantation Burst Pressure Over Time in a Porcine Model 3 Burst Pressure (N) After 8 weeks maintains burst pressure at approximately 7x the max IAP Due to fastener holding strength and aggressive tissue ingrowth through the hollow core. 0 T=0 2 weeks 4 weeks 8 weeks Weeks Post Implantation Burst Pressure Maximum Intraabdominal Pressure 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. 5

6 A Complete Open Ventral Hernia Repair Solution 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 time 3 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 success 5 3 Preclinical data on file. Results may not correlate to clinical outcomes. 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 Jan; 206 (1):

7 OptiFix Open Absorbable Fixation System Indications 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 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. 7

8 Absorbable Fixation System OptiFix Open Absorbable Fixation System Catalog Number Configuration Qty Absorbable Fasteners 5/case Ventrio ST Hernia Patch Catalog Number Shape Mesh Size Qty Small Oval Medium Oval Large Oval 3.1" x 4.7" (8.0 cm x 12.0 cm) 4.3" x 5.5" (11.0 cm x 14.0 cm) 5.4" x 7.0" (13.8 cm x 17.8 cm) Small Circle 3.0" (7.6 cm) diameter Large Circle Extra Large Oval Extra Large Oval Extra Large Oval Midline Ventrio Hernia Patch 4.5" (11.4 cm) diameter 7.7" x 9.7" (19.6 cm x 24.6 cm) 8.7" x 10.7" (22.1 cm x 27.1 cm) 10.8" x 13.7" (27.4 cm x 34.9 cm) 6.1" x 10.1" (15.5 cm x 25.7 cm) Catalog Number Shape Mesh Size Qty Small Oval Large Oval Small Circle Large Circle Medium Oval Extra Large Oval Extra Large Oval Extra Large Oval Oval 3.1" x 4.7" (8.0 cm x 12.0 cm) 5.4" x 7.0" (13.8 cm x 17.8 cm) 3.0" (7.6 cm) diameter 4.5" (11.4 cm) diameter 4.3" x 5.5" (11.0 cm x 14cm) 8.7" x 10.7" (22.1 cm x 27.1 cm) 10.8" x 13.7" (27.4 cm x 34.9 cm) 7.7" x 9.7" (19.6 cm x 24.6 cm) 6.3" x 12.3" (16.0 cm x 31.2 cm) Ventralex ST Catalog Number Shape Mesh Size Qty Ventralex Small Circle Medium Circle Large Circle 1.7" (4.3 cm) diameter 2.5" (6.4 cm) diameter 3.2" (8.0 cm) diamter Catalog Number Shape Mesh Size Qty Order Form Small Circle Medium Circle Large Circle 1.7" (4.3 cm) diameter 2/cs. 2.5" (6.4 cm) diameter 2/cs. 3.2" (8.0 cm) diameter 2/cs. Please add these products to my preference card. I would like to have these products in stock. (Reference catalog numbers checked) I would like to trial these products. Purchase Order Number Catalog Number(s) Surgeon s Signature Date Quantity To learn more, contact your local Bard Representative or call 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. Davol Inc. Subsidiary of C. R. Bard, Inc. 100 Crossings Boulevard Warwick, RI Medical Services & Support DAV/OPOP/0317/0004