Phasix™ ST Mesh with Echo 2™ Positioning System

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.

1. Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. The use of this mesh in susceptible patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.
2. 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.
3. Ensure proper orientation; the coated side of the mesh 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 erosions when the uncoated mesh side is placed in direct contact with the bowel or viscera.
4. 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.
5. The safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated.
6. The use of any synthetic mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh and it is not recommended.
7. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require the removal of the mesh.
8. To prevent recurrences when repairing hernias, Phasix™ ST Mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.
9. The safety and effectiveness of Phasix™ ST Mesh in the following applications has not been evaluated or established: a. pregnant or breastfeeding women b. pediatric use c. Neural and cardiovascular tissue.
10. The device should be used once exterior foil pouch has been opened. Do not store for later use.
11. Unused portions of the device should be discarded. If unused mesh has been in contact with instruments or supplies used on a patient or contaminated with body fluids, discard mesh with care to prevent risk of transmission of viral infections.
12. This device is provided sterile and has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging any portion of the device may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient.
13. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user.
14. 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.
15. This device contains superelastic nitinol wire; do not cut and avoid direct contact/coupling with active surgical electrodes.
16. The Echo 2™ Positioning System should not be used with any other hernia device aside from those with which it comes preattached/packaged.
17. Discard the Echo 2™ Positioning System (including the frame, center hoisting suture, all connectors) and introducer tool after use. There may be a potential biohazard. Handle and dispose in accordance with accepted medical practice and applicable local state and federal laws and regulations.
18. Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black.
19. When using Phasix™ ST Mesh laparoscopically or robotically in IPOM placement, appropriate surgical technique is recommended to reestablish the fascial integrity of the abdominal wall. As Phasix™ ST Mesh is a bioresorbable mesh, and does not provide permanent wound support, robust fascial closure and management of tension during closure is important to reduce possible hernia recurrence. In the event recurrence is suggested or noted, the clinician should evaluate additional therapeutic or surgical options.
20. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach.
21. This mesh is not for the use of treatment of stress urinary incontinence.

Precautions.

1. Please read all instructions prior to use.
2. Only physicians qualified in the appropriate surgical techniques should use this device. Users should be familiar with mesh strength and size requirements. Improper selection, placement, positioning, and fixation of the mesh can cause subsequent undesirable results.
3. The safety and effectiveness of the mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity.
4. Do not trim the Phasix™ ST Mesh. This will affect the interference between the mesh and the positioning system.
5. 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.
6. The safety and effectiveness of Phasix™ ST Mesh in the proximity of existing or excised cancer has not been established.

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.

Please consult package insert for more detailed safety information and instructions for use.  

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.

1. Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. The use of this mesh in susceptible patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.
2. 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.
3. Ensure proper orientation; the coated side of the mesh 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 erosions when the uncoated mesh side is placed in direct contact with the bowel or viscera.
4. 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.
5. The safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated.
6. The use of any synthetic mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh and it is not recommended.
7. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require the removal of the mesh.
8. To prevent recurrences when repairing hernias, Phasix™ ST Mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.
9. The safety and effectiveness of Phasix™ ST Mesh in the following applications has not been evaluated or established: a. pregnant or breastfeeding women b. pediatric use c. Neural and cardiovascular tissue.
10. The device should be used once exterior foil pouch has been opened. Do not store for later use.
11. Unused portions of the device should be discarded. If unused mesh has been in contact with instruments or supplies used on a patient or contaminated with body fluids, discard mesh with care to prevent risk of transmission of viral infections.
12. This device is provided sterile and has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging any portion of the device may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient.
13. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user.
14. 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.
15. This device contains superelastic nitinol wire; do not cut and avoid direct contact/coupling with active surgical electrodes.
16. The Echo 2™ Positioning System should not be used with any other hernia device aside from those with which it comes preattached/packaged.
17. Discard the Echo 2™ Positioning System (including the frame, center hoisting suture, all connectors) and introducer tool after use. There may be a potential biohazard. Handle and dispose in accordance with accepted medical practice and applicable local state and federal laws and regulations.
18. Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black.
19. When using Phasix™ ST Mesh laparoscopically or robotically in IPOM placement, appropriate surgical technique is recommended to reestablish the fascial integrity of the abdominal wall. As Phasix™ ST Mesh is a bioresorbable mesh, and does not provide permanent wound support, robust fascial closure and management of tension during closure is important to reduce possible hernia recurrence. In the event recurrence is suggested or noted, the clinician should evaluate additional therapeutic or surgical options.
20. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach.
21. This mesh is not for the use of treatment of stress urinary incontinence.

Precautions.

1. Please read all instructions prior to use.
2. Only physicians qualified in the appropriate surgical techniques should use this device. Users should be familiar with mesh strength and size requirements. Improper selection, placement, positioning, and fixation of the mesh can cause subsequent undesirable results.
3. The safety and effectiveness of the mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity.
4. Do not trim the Phasix™ ST Mesh. This will affect the interference between the mesh and the positioning system.
5. 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.
6. The safety and effectiveness of Phasix™ ST Mesh in the proximity of existing or excised cancer has not been established.

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.

Please consult package insert for more detailed safety information and instructions for use.