CapSure™ Permanent Fixation System - 30 Permanent Fasteners

1. Bench top data. Results many not correlate to performance in humans.

2 Preclinical data. Results may not correlate to performance in humans

Indications

The CapSure™ Permanent 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

Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera. Use of the CapSure™ Permanent Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is another 1 mm (total 4.2 mm).

Precautions

Adequate counter pressure should be applied on the target area. Avoid placing hand or finger directly over the area where fastener is being deployed to prevent injury. Use caution when applying the CapSure™ fastener over or in proximity to underlying bone, vessels, nerves, or viscera. The intended fixation site should be assessed to ensure that while the tissue is compressed the total distance from the surface of the tissue to any underlying structures is greater than the length of the CapSure™ fastener. Adverse Reactions

Adverse reactions and potential complications associated with fixation devices such as the CapSure™ Permanent Fixation System may include, but are not limited to the following: hemorrhage, pain, edema and erythema at wound site; septicemia/infection; hernia recurrence/wound dehiscence, erosion and allergic response in patients with known sensitivities to PEEK and metals contained in 316L stainless steel, including chromium, nickel, copper, and iron.