Phasix™ ST Mesh with Echo 2™ Positioning System, Ellipse, 8 in x 10 in (20 cm x 25 cm)

1. Surgeon survey. Data on file. Preclinical testing. Results may not correlate to clinical performance.

2. Time test compared to flat sheet. Preclinical testing. Data on file. Results may not correlate to clinical performance.

3. Data on file. Based on preclinical testing. Results may not correlate to clinical performance in humans.

4. In preclinical testing compared to Bio-A®, Vicyrl® Mesh, and OviTex™ Resorbable Mesh. Data on file. Results may not correlate to clinical performance in humans.

Indications

Phasix™ ST Mesh 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. The Echo 2™ Positioning System is intended to facilitate the delivery and positioning of the mesh during laparoscopic hernia repair.

Contraindications

Because Phasix™ ST Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device in patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.

Phasix™ ST Mesh is the only implantable component of the device. The Echo 2™ Positioning System (which includes the frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.

Ensure proper orientation; the hydrogel coated side of the device should be oriented against the bowel or sensitive organs. Do not place the uncoated mesh side against the bowel. There is a risk for adhesion formation or erosionswhen the uncoated mesh side is placed in direct contact with the bowel or viscera.

Deviation from recommended instructions and/or procedural steps within this IFU may result in disruption or delamination of the hydrogel barrier of the mesh. Hydrogel disruption or delamination may cause an unexpected increase in adhesion formation in the area where it is disrupted.

The safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established.

The safety and effectiveness of Phasix™ ST Mesh in the following applications has not been evaluated or established:

• Pregnant women
• Pediatric use

Neural and Cardiovascular tissue

If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the mesh.

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 device aside from those with which it comes preattached/packaged.

Adverse Reactions

In preclinical testing, Phasix™ ST Mesh elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the mesh was resorbed. Possible complications may include, but are not limited to, seroma, adhesion, hematoma, pain, infection, inflammation, allergic reaction, hemorrhage, extrusion, erosion, migration, fistula formation and recurrence of the hernia or soft tissue defect.

Precautions

The safety and effectiveness of the mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity.

Do not trim the Phasix™ ST Mesh. This will affect the interface between the mesh and the posi tionin g 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.

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