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Angio-Seal™ Evolution™

Vascular Closure Device

Description

Simple.Proven. Fast Sealing.


Angio-Seal is a medical device indicated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures (minimal artery diameter of 4mm).  

The 6F Angio-Seal device is for closure after usage of a 6 French or smaller procedural sheath, while the 8F Angio-Seal device is for closure after usage of an 8 French or smaller procedural sheath. 

Characteristics

  • Insertion Sheath
  • Arteriotomy Locator
  • 6F (2.0 mm) – 0.035 in. (0.89 mm) Guidewire with J-Straightener or 8F (2.7 mm) – 0.038 in. (0.96 mm) Guidewire with J-Straightener
  • Angio-Seal consists of 3 bioabsorbable components: anchor, collagen, and suture
  • 10 units per box
  • Single use, one year shelf life after sterilization
  • Sterilized by gamma radiation. Do not re-sterilize
  • Available in select markets 

Storage, packaging and disposal:

  • Should be stored in a cool location (between 15°C and 25 °C)
  • Contains resorbable materials that degrade by exposure to heat and moisture; therefore, the device may not be resterilized
  • Sterile and non-pyrogenic in unopened and undamaged package
  • Dispose of contaminated units, components, and packaging materials utilizing standard hospital procedures and universal precautions for biohazardous waste.

Procedure

Step by step instructions

1

Locate the artery

  • Introduce the locator into the insertion sheath (arrow to arrow) and a click should be heard. Thread the Angio-Seal assembly over the guidewire and insert it into the artery
  • Blood flow through the drip hole of the locator confirms sheath has entered the artery.
  • Confirm proper location by withdrawing and reinserting the locator system about 1.5 cm until blood flow resumes.
  • Remove locator and wire maintaining the position of the sheath in place.
2

Set the anchor

  • Carefully grasp the Angio-Seal device just behind the bypass tube and slowly insert into the sheath until sheath cap and device sleeve snap together. A click should be heard.
  • Maintaining a grip on the sheath cap, grasp device handle and gently pull back until device handle and sleeve snap lock. The white coloured bands should be exposed and a click should be heard.
3

Set the seal

  • Gently pull back the device assembly along the angle of the puncture tract. A resistance should be felt.
  • Pull back on the device maintaining a steady uninterrupted motion until the colored compaction marker is revealed. Pause and assess for hemostasis. Hold the device for 10 seconds for hemostasis.
4

Release the suture

  • Release and hold down the suture release button.
  • Gently push back the device handle until the suture is exposed and the compaction tube is removed from the tissue tract.
  • With tension on the suture, cut the suture below skin level. Clean puncture site and apply a sterile dressing so that it can easily be observed during recovery.

Clinical evidence

Reduced Rate and Cost Of Complications

View study
Increased-Patient-Satisfaction-and-Comfort

View study
Improved-Lab-Efficiency

View study

General specifications

Content ​ ​​Vascular closure device
​Insertion sheath
​Arteriotomy locator
​70 cm guidewire with "J" straightener
​Units per box10​

Item specifications

​Item reference​French size​Guidewire diameter (in)
​C610136​6​0.035
​C610137​8​0.038

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