OptiFix™ Absorbable Fixation System
OptiFix™ Absorbable Fixation 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.
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
- 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
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. This device is not intended for use except as indicated.
- 2. Do not use this device where hemostasis cannot be verified visually after application.
- 3. Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply, including but not limited to:
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- 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.
- 4. 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).
- 5. This device should not be used in tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of fasteners in the diaphragm in the vicinity of the pericardium, aorta, or inferior vena cava during diaphragmatic hernia repair.
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™ 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.
