OptiFix Absorbable Fixation System

Transcription

1 OptiFix Absorbable Fixation System Absorbable Fixation Redefined Advancing the Fixation Experience. SOFT TISSUE REPAIR Right Procedure. Right Product. Right Outcome.

2 Hernia Repair Fixation Challenges and Opportunities in Absorbable Fixation Absorbable Fixation devices can provide important benefits and lead to repeatable outcomes. However, Absorbable Fixation devices that facilitate soft tissue repair may also be associated with certain challenges, such as: Excessive deployment force may cause tissue trauma and bleeding 1 Fasteners may be difficult to see laparoscopically potentially leading to the placement of unnecessary fasteners Device may be uncomfortable or awkward to deploy in smaller sized hands and may be sensitive to surgeon technique OptiFix Absorbable Fixation System Surgeon confidence through a performance-driven system The OptiFix Absorbable Fixation System has been engineered inside and out to provide surgeon confidence and secure fixation in a reliable, easy to use, and ergonomic design. and Available in both 30 and 15 fastener count options Spring Loaded Trigger Releases stored energy to smoothly deliver fasteners through mesh and into tissue with a lower counterpressure requirement than other fixation devices Ensures consistent fastener deployment Comfort Grip Handle Designed to fit a wide range of surgeon hand sizes

3 OptiFix Absorbable Fixation System Outcome-driven fixation The OptiFix 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 1 Ensures mesh is securely fixated Hollow Core Design Allows tissue ingrowth through the fastener 1 Angled Tip Easily penetrates mesh and tissue Stabilizers Enhances tissue holding strength Prevents the fastener from backing out Enlargement Metric Scale Facilitates laparoscopic measurements Textured Tip Ensures tip stability during fastener deployment 39cm Cannula Length the longest available Provides laparoscopic reach allowing for greater positioning flexibility and access 1 Preclinical data on file. Results may not correlate to clinical outcomes. Optimally designed Fixation System for outcome-driven results

4 Fixate with Confidence OptiFix fasteners provide secure fixation during the postoperative healing period then slowly resorbs over time Baseline Strength Retention 2 Burst Pressure Over Time in a Porcine Model 3 120% (n=10) 350 Burst Pressure (n < =10) 100% % 60% 40% 20% 0 T= 0 8 weeks 32 weeks Weeks Post Implantation Units (Newtons) T=0 2 weeks 4 weeks 8 weeks Weeks Post Implantation > = Burst Pressure Maximum Interabdominal Pressure (IAP) OptiFix fastener maintains its strength through the crucial healing period, then begins to resorb. Minimal degradation of the fastener during the healing period, along with aggressive tissue ingrowth maintains burst pressures at approximately 7x the Intra-abdominal Pressure (IAP) requirement needed for the repair. See the Difference Fastener Visibility and Mesh Retention Surface Area 5X magnification 2 OptiFix AbsorbaTack SecureStrap 9.0 mm mm mm 2 Higher fastener surface area coverage results in more visible fasteners and more secure mesh fixation. 2 2 C.R. Bard Inc., bench data on file. 3 Preclinical data on file. Results may not correlate to clinical outcomes.

5 Controlled Deployment Optimized deployment force and fastener head geometry ensures secure fixation and may minimize trauma and bleeding. In a preclinical study, OptiFix demonstrated significantly less fastener site hemorrhaging than SecureStrap. OptiFix experienced 9X less incidents of bleeding than SecureStrap. 3 OptiFix with Ventralight ST SecureStrap with PhysioMesh ST The larger head of OptiFix reduces stress OptiFix SecureStrap OptiFix has 5X more mesh retaining surface than SecureStrap 2 3 Preclinical data on file. Results may not correlate to clinical outcomes. OptiFix is engineered inside and out to provide surgeon confidence

6 Fixate with Confidence Preferred Ergonomic Feel and Design Surgeon Feedback 4 Surgeons prefer the handling of OptiFix versus other fixation devices 50 Overall Preference for Fit, Feel and Fire In a blind preference test assessing surgeons preference of device comfort, trigger force, and overall fit, feel and fire, OptiFix was preferred nearly 4x more frequently than the next closest competitor. Number of Surgeons AbsorbaTack SecureStrap OptiFix A fixation device designed with the surgeon and patient in mind. 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 Survey of surgeons attending an international surgical conference. Data on file.

7 OptiFix supports your procedure of choice. With Ventralight ST Mesh with Echo 2 PS Positioning System in Laparoscopic Ventral Procedures Provides secure fixation in laparoscopic ventral procedures Penetrates and holds larger pore mesh as well as dual layer and/or smaller pore mesh Compatible in lap ventral with all Bard mesh configurations including Ventralight ST, Composix L/P, and Ventrio ST OptiFix Absorbable Fixation System Indications The OptiFix Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. Contraindications 1. Contraindications associated with laparoscopic and 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 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 1. 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 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 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. Ventralight ST Mesh with Echo 2 Positioning System Indications Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo 2 Positioning System is intended to facilitate the delivery and positioning of the soft tissue prosthesis during laparoscopic hernia repair. Contraindications Do not use the device in infants, children or pregnant women, whereby future growth will be compromised by use of such material. Do not use for the reconstruction of cardiovascular defects. Literature reports there is a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera. Warnings The use of any synthetic mesh in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh and is not recommended. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. Unresolved infection may require removal of the mesh Ventralight ST Mesh is the only permanent implant component of the device. The Echo 2 Positioning System (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded. It is not part of the permanent implant. Do not apply sharp, pointed, cautery devices, or ultrasonic tools (such as scissors, needles, tackers, diathermic tools, etc.) to the Echo 2 Positioning System frame. The device contains superelastic nitinol wire; do not cut and avoid direct contact/coupling with active surgical electrodes. The Echo 2 Positioning System should not be used with any other hernia prosthesis aside from those with which it comes pre-attached/packaged. Precautions Do not trim the mesh. This will affect the interface between the mesh and the positioning system. Visualization must be maintained throughout the course of the entire surgical procedure. Additionally, laparoscopic removal of the Echo 2 Positioning System frame must be performed under sufficient visualization of the entire device and surrounding anatomy, to ensure proper removal. Adverse Reactions Possible complications may include, but are not limited to, seroma, adhesion, hematoma, pain, infection, inflammation, extrusion, erosion, migration, fistula formation, allergic reaction and recurrence of the hernia or soft tissue defect.

8 OptiFix Absorbable Fixation System OptiFix Absorbable Fixation System Catalog Number Configuration Qty Absorbable Fasteners 5/case Absorbable Fasteners 5/case Order Form Please add these marked products to my preference card. I would like to have these marked products in stock. (Reference catalog numbers checked) I would like to trial these marked products. Purchase Order Number Date Catalog Number(s) Quantity Surgeon s Signature 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, Echo 2, OptiFix, Ventralight, Composix and Ventrio are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. Copyright 2018, C. R. Bard, Inc. All Rights Reserved. Davol Inc. Subsidiary of C. R. Bard, Inc. 100 Crossings Boulevard Warwick, RI Medical Services & Support DAV/OPFX/0315/0012(3)