OptiFix™ AT Absorbable Fixation Systemwith Articulating Technology A whole new angle on fixation.

OptiFix™ AT is an articulating device that allows for traditional straight fixation plus the option to articulate the tip to better access areas where mesh fixation may otherwise be difficult, such as locations close to the trocar.

The ergonomic device is designed to:1 • Provide full mesh access from one side of the patient.• Deliver more consistent perpendicular fastener deployment.• Enhance surgeon comfort.

Challenges with traditional straight fixation devices1,2

• Literature suggests that non-articulating fixation devices may not fully access mesh from a single port location or ensure perpendicular fastener deployment in challenging conditions.

• Recommended tack deployment angle is often difficult to achieve and may require excess traction placed on ports and the placement of additional ports.

• Technical limitations may also result in non-ideal fastener placement, which is a mechanism for mesh shift, migration, inadequate mesh overlap, folding and fastener dislodgement.

OptiFix™ AT Absorbable Fixation Systemwith Articulating Technology

37 cm cannulaArticulation lever

Preloaded with 15 or 30 fasteners eliminates the need for disruptive cartridge changes.

A whole new angle on fixation.

Four position rotating handlelocks every 90º

1 Moore A, Chen D. "Articulating and reloadable fixation devices for hernia repair". SurgTech Int. 2017 August: XXVIII2 Liang MK, Clapp ML, Garcia A, Subramania A, Awad SS. "Mesh shift following laparoscopic ventral hernia repair" J Surg Res. 2012 E7-E13.3 Data generated in a preclinical model. Results may not correlate to performance in humans.

Absorbable poly (L-lactide-co-glycolide) PLG fastener. Designed for optimal performance.3

Smooth fastener head3

• Minimizes the potential for tissue attachments.

Hollow core design3

• Allows tissue ingrowth through the fastener.

Angled tip • Easily penetrates mesh and tissue.

Stabilizing prongs • Enhances tissue holding strength.• Prevents the fastener from backing out.

OptiFix™ AT absorbable fasteners maintain 100% of their strength through the crucial postoperative healing period (28 days) and then resorb over time.3,4

4 OptiFix™ AT IFU

Textured tip designed for distal tip stability 55º

deployment angle

6.5 mm depth of purchase

Enlargement

• Allows for traditional straight fixation plus the option of an articulating tip for perpendicular fastener deployment on ipsilateral and contralateral sides.

• Improved access may reduce total number of trocars needed. Studies demonstrate that reducing trocars can result in cost savings, reduced risk of infection and trocar site herniation.3,5-9

OptiFix™ AT

Contralateral side

Trocar

Bowel

Insufflated cavityeasier zone to fasten

Mesh

OptiFix™ AT design allows for fixation from close proximity to the trocar.

Ipsilateral side

Full mesh access from one side of the patient

5 H. Tran, I. Turingan, K. Tran, M. Zajkowska, W. Lab, W. Hawthorne. Potential benefits of single-port comparted to multiport laparoscopic inguinal herniorraphy: a prospective randomized controlled study.6 SILS Literature Review; Prepared by: Shawna Evans, Halloran Consulting Group.7 Greaves N, Nicholson J. Single incision laparoscopic surgery in general surgery: a review. Ann R Coll Surg Engl. 2011 Sep;93(6):437-40. doi: 10.1308/003588411X5903588 Vidal O, Valentini M, Ginestà C, Espert JJ, Martinez A, Benarroch G, Anglada MT, García-Valdecasas JC. Single-incision versus standard laparoscopic cholecystectomy: comparison of surgical outcomes from a single institution. J Laparoendosc Adv Surg Tech A. 2011 Oct;21(8):683-6. doi: 10.1089/lap.2011.0047. Epub 2011 Jul 20.9 Wagner MJ, Kern H, Hapfelmeier A, Mehler J, Schoenberg MH. Single-port cholecystectomy versus multi-port cholecystectomy: a prospective cohort study with 222 patients. World J Surg. 2013 May;37(5):991-8. doi: 10.1007/s00268-013-1946-4.

Procedural efficiency

Reloading cartridges = procedural disruptionThe ReliaTack™ device requires multiple cartridge changes to obtain the fastener counts commonly used to secure mesh in hernia procedures. Each cartridge change requires halting the repair, removing the device from the abdomen and completing 8 steps to unload and reload the device.10

• Preloaded with 15 or 30 fasteners. No cartridges = time savings.• One-step articulation, “engage and go” with simple lever.• Minimal change to current technique.

10 ReliaTack™ IFU

Rotating handle and articulating tip to easily and fully access mesh from one side of the patient.

Straight fixation devices require challenging positions to get perpendicular fastener deployment and multiple ports are needed to fully access the mesh.

Competitor straight fixation deviceOptiFix™ AT Absorbable Fixation System with Articulating Technology

Position 1

Position 3

Position 2

Position 4

OptiFix™ AT Absorbable Fixation System with Articulating Technology

SECURESTRAP® Absorbable Strap Fixation Device

• Enables secure fixation across the entire mesh, on the contralateral side and close to the trocar.• Leads to improved fastener tissue purchase and fixation strength.• Facilitates mesh positioning and reduces the chance for mesh to be pulled away during fastening.

Consistent perpendicular fastener deployment1

Side-by-side comparison

OptiFix™ AT ReliaTack™ SECURESTRAP®

Able to fixate with tip straight or articulated

One step to articulate

No cartridge changes required, minimizes disruption to current device technique

Spring loaded trigger for consistency and ease-of-use

Preloaded with 15 or 30 fasteners

Four position rotating handle

Smooth fastener head with hollow core for tissue ingrowth3

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.

Order form

Purchase order number

Date

Catalog number(s)

Quantity

Surgeon’s signature

OptiFix™ AT Absorbable Fixation System

Cat. no. Description Qty.

0113330 30 absorbable fasteners 5/case

0113315 15 absorbable fasteners 5/case

OptiFix™ AT Absorbable Fixation System with Articulating TechnologyIndicationsOptiFix™ AT Absorbable Fixation System with Articulating Technology 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, cartilage or bone. For reference, the length of the fastener below the fastener head is 6.5 mm, and the fastener head is another 0.6 mm (total 7.1 mm).

WarningsRemove the yellow clip prior to use of device. Do not use device if the yellow clip is damaged or not in place. 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™ AT Absorbable Fixation System with Articulating Technology may be a potential biohazard. Handle and dispose of in accordance with any local and federal laws regarding medical waste.

Adverse ReactionsAdverse reactions and potential complications associated with fixation devices such as the OptiFix™ AT Absorbable Fixation System with Articulating Technology may include, but are not limited to the following: hemorrhage; pain, edema and erythema at wound site; allergic reaction to Poly (L, lactide-co-glycolide); infection/septicemia; hernia recurrence/wound dehiscence.

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

Side-by-side comparison

BD, Warwick, RI, 02886, U.S. 800.556.6275

bd.comBD, the BD Logo and OptiFix are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. © 2019 BD. All rights reserved.DAV/OPAT/0317/0002(1)