VenaSeal™
Closure System
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.
ClosureFast, Covidien, Medtronic, VenaSeal
Definition of symbols
Sterilized using ethylene oxide
Lot number
Consult instructions for use at this website
Use-by date
Do not use if package is damaged
Keep dry
Manufacturer
Catalog number
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
Sterilized using steam or dry heat
Do not reuse
Do not resterilize
Nonpyrogenic
Straight floppy tip guidewire
Quantity
3
Contents
1 Device description ................................................................................................. 5
2 Indications for use ................................................................................................. 5
3 Contraindications ................................................................................................. 5
4 Warnings and Precautions ............................................................................................ 5
4.1 Warnings ...................................................................................................... 5
4.2 Precautions ..................................................................................................... 5
5 Potential adverse events ............................................................................................. 5
6 Summary of clinical studies ........................................................................................... 6
7 Primary clinical study (VeClose) ........................................................................................ 6
7.1 Study design .................................................................................................... 6
7.2 Clinical inclusion and exclusion criteria ..................................................................................... 6
7.3 Study population demographics and baseline parameters ......................................................................... 7
7.4 Procedural data .................................................................................................. 8
7.5 Safety and effectiveness results ......................................................................................... 8
8 How supplied ................................................................................................... 10
9 Storage ....................................................................................................... 11
10 Directions for use ................................................................................................ 11
10.1 Recommended accessories ......................................................................................... 11
10.2 Preparation ................................................................................................... 11
10.3 Access ...................................................................................................... 11
10.4 Assembly .................................................................................................... 11
10.5 Procedure .................................................................................................... 12
10.6 If the primed catheter needs to be withdrawn from the introducer prior to completion, take the following steps: ........................................ 13
10.7 Total amounts of VenaSeal adhesive expected for use in vein treatments .............................................................. 13
11 Disposal ...................................................................................................... 14
12 Disclaimer of warranty ............................................................................................ 14
4
1 Device description
VS-404
The VenaSeal closure system is a medical device provided as a sterile, single patient kit comprised of the VenaSeal adhesive and VenaSeal delivery system components. The kit is designed
to be used as a system, and its contents are not intended for use as individual components. The VenaSeal system is intended to be used by a licensed physician while using high resolution
ultrasound imaging. The VenaSeal system is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular
embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
The VenaSeal adhesive, an n-butyl-2-cyanoacrylate (n-BCA) based formulation, is a clear, free-flowing liquid that is provided sterile following exposure to dry heat. The VenaSeal adhesive
polymerizes in the vessel via an anionic mechanism (i.e., VenaSeal adhesive begins to polymerize into a solid material upon contact with body fluids or tissue). This acute coaptation halts
blood flow through the insufficient vein until the implanted adhesive becomes fibrotically encapsulated to establish a durable, chronic occlusion of the treated vein. The VenaSeal delivery
system components facilitate the placement and delivery of VenaSeal adhesive within the target vessel. The VenaSeal delivery system components include a catheter, introducer, dilator,
dispenser gun, dispenser tips, 3 cc syringes, and 0.035 in straight floppy tip guidewire. The VenaSeal system kit is provided sterile by exposure to ethylene oxide (EtO).
Figure 1. VenaSeal closure system
2 Indications for use
The VenaSeal closure system (VenaSeal system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through
endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
3 Contraindications
Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system.
The use of the VenaSeal system is contraindicated when any of the following conditions exist:
• previous hypersensitivity reactions to the VenaSeal adhesive or cyanoacrylates
• acute superficial thrombophlebitis
• thrombophlebitis migrans
• acute sepsis
Prior to use, read all package insert warnings, precautions and instructions. Failure to do so may result in severe patient injury and/or death.
4 Warnings and Precautions
4.1 Warnings
• The VenaSeal system should only be used by a trained physician with experience in diagnosis and treatment of venous reflux disease through endovenous techniques. Physicians require
training using the VenaSeal system by the manufacturer prior to performing this procedure independently.
• Due to the risk of exposure to HIV or other blood borne pathogens, health care workers should always use standard blood and body fluid precautions in the care of all patients. Strictly
adhere to sterile techniques during any handling of the device.
• The VenaSeal system is not designed for use in the coronary and cerebral vasculature, pulmonary vasculature, or diseased and atherosclerotic arteries.
• Do not flush the catheter with saline or fluid as this will make it unusable with the VenaSeal adhesive.
• Manipulate the catheter only under ultrasound imaging guidance.
• Confirm position of the catheter tip in the desired location by ultrasound imaging before activation of the device.
• Injection of the VenaSeal adhesive should be done by hand injection only and using the VenaSeal delivery system provided. Do not use a power injector.
• Do not kink the catheter. Do not use the catheter if it is kinked.
• Use the introducer in the VenaSeal delivery system for access to the peripheral vasculature. Failure to use the introducer for access may result in damage to the vessel, or failure of the
VenaSeal system to perform as intended.
4.2 Precautions
• The safety and effectiveness of the VenaSeal system in pregnant women and in pediatric patients have not been established.
• The VenaSeal system is sterile unless the package is opened or damaged. Examine the package before using the system. If the package is damaged, do not use the system.
• The VenaSeal system is supplied sterile for single use only. Do not reprocess or resterilize. Reprocessing and resterilizing could increase the risk of patient infections and risk of
compromised device performance.
• Before using, carefully examine the VenaSeal closure system components and verify that they and their packaging have not been damaged during shipment. If the components show any
sign of damage, do not use the system.
• Do not use after the use-by date.
• Verify that the VenaSeal adhesive is a clear and free-flowing liquid prior to use. Adhesive that is discolored should be discarded.
• The VenaSeal adhesive will adhere to most surfaces. Avoid contact with non-disposable surfaces.
• Gloves and eye/face protection are recommended when handling the VenaSeal adhesive.
• The VenaSeal adhesive is intended to be delivered via the VenaSeal delivery system components only.
5 Potential adverse events
The potential adverse events (e.g., complications) associated with the use of the VenaSeal system include, but are not limited to, the following list:
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