{"AlternateComparison":false,"RelatedProducts":true,"Specification":true,"FeatureBenefit":false}
Phasix™ Synthetic mesh Phasix™ ST Mesh with Echo 2™ Positioning System

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

Icon to close the modal
Support
Sales
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Modal Close Icon

Capability:

Product Line:

Icon to close thank you modal
Thank you for contacting our sales team!
A sales representative will get in touch with you shortly.
Ordering
Phone Icon
1.800.556.6756
BDISurgery@bd.com
Onsite Visiting
Location Icon
100 Crossings BoulevardWarwick, Rhode Island 02886United States
Customer Service
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Monday to Friday 8:15 AM to 6:00 PM EST
Fax Icon
1.800.531.4124
Custserv.davol@bd.com
Shipping a Product Back
Location Icon
100 Crossings Boulevard, Warwick, Rhode Island 02886, United States
Overview

Simplify the complex

Introducing the only bioresorbable mesh with a positioning system designed to streamline laparoscopic and robotic hernia repairs.

true
Features and Benefits
Promotional Story
false
References

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.

true
Specification

GTIN - Case

00801741161285

1


Quantity

1/cs.


Dimensions

Ellipse 8" x 10" (20 cm x 25 cm)

GTIN

GTIN - Case 00801741161285 1

Packaging

Quantity 1/cs.

Product Basic Specification

Dimensions Ellipse 8" x 10" (20 cm x 25 cm)
References
false
Electronic Instructions for Use (eIFUs)
Resources
References
false
Frequently Asked Questions
false
References
false
Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
Product Recalls
Literature Icon
Recall Notifications
These recall notices provide current information on medical device recalls.
Learn more
References
false
false