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Bard - 5955810 - Bard Davol Ventralight St With Echo Ps Ellipse
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Ventralight ST Mesh or Composix L/P Mesh with a pre-attached low-profile balloon to help facilitate deployment, placement and positioning in laparoscopic ventral hernia repair.
1 When compared to positioning with transfascial sutures in a preclinical study.
Date on file at C. R. Bard, Inc. Results may not correlate to performance in humans.
INDICATIONS
Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. Composix L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PS Positioning System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.
CONTRAINDICATIONS
Literature reports there is a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera.
WARNINGS
Ventralight ST Mesh/Composix L/P Mesh is the only permanent implant component of the device. The inflation adapter and syringe are to be kept external to the patient and discarded after use. The Echo PS Positioning System (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant.
The Echo PS Positioning System should not be used with any other hernia prosthesis aside from those with which it comes pre-attached/packaged.
PRECAUTIONS
Do not trim the mesh. This will affect the interface between the mesh and positioning system.
ADVERSE REACTIONS
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect.
Please consult package insert for more detailed safety information and instructions for use.
DAV/ECAS/0917/0042
Key Benefits
Mesh Preparation
- Comes pre-attached with either Ventralight ST Mesh or Composix L/P Mesh.
- Designed to ensure that barrier protection is oriented towards viscera.
- Reduces mesh preparation time and user frustration.1
Deployment
- Does not require dedicated trocar.
- Potentially reduces patient trauma.
- Following mesh introduction, trocar is free to be used with other laparoscopic instruments.
Positioning
- Technique designed to center mesh over defect.
- Alleviates guesswork and facilitates centering.
Compared to positioning with transfascial sutures, Echo PS Positioning System:
- Reduces mesh positioning by over 60%1
- Reduces procedure time variability by 84%1
Fixation
- Requires only one set of hands.
- Once positioned with the Echo PS Positioning System, mesh stays in place allowing the surgeon to use both hands for fixation.
- No assistance or handoff needed to hold mesh in place during fixation potentially leading to increased accuracy.
- Unique flexible balloon design.
- Allows mesh to conform to the abdominal wall.
- Occupies less intraabdominal space and is designed not get in the way of fixation.
Manufacturer | Bard Rochester |
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Code | 5955810 |
MPN | 5955810EA |
Sold By | Each |
HCPCS | - |
GTIN | 801741031786 |
Product Size | 8" X 10" |
WHSXX | GES |