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Angio-Seal™ Evolution

Controlled Deployment for Confident Closure

Angio-Seal Evolution features a standardized deployment system that is designed to assist in overcoming many procedural variables and deliver a virtually instantaneous seal of the arteriotomy. It may also support increased confidence in the number of cases where the use of a mechanical seal is possible.

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Overview

Active Closure System

Angio-Seal Evolution features the fully bioabsorbable Active Closure System with an innovative intra-arterial anchor, suture and collagen seal. Designed to hold the system in place, the Active Closure System provides rapid, safe and reliable hemostasis.

Active Closure System

 

Bioabsorbtion Rate of Anchor

Delivery Components

Angio-Seal Device

Sheath

Provides a platform for device deployment. Made of Pebax®.

Ateriotomy Locator

Used with the sheath, the arteriotomy locator provides optimal positioning for Angio-Seal device deployment. Made of polythylene.

Guidewire

A 70cm, .035-inch guidewire is provided with the 6F system to perform a sheath exchange. A 70cm, .038-inch guidewire is provided with the 8F system.


For more information related to Angio-Seal please visit the following sites:

The Knowledge Center is an online resource for interventional cardiologists. The website provides a complete collection of education materials related to PCI optimization - Fractional Flow Reserve and Optical Coherence Tomography - as well as Access and Closure. 

Clinical Discoveries provides background information on clinical challenges and research. It also provides access to clinical resources, such as downloadable PowerPoint presentations and publication

References

Pebax is a registered trademark of Arkema.

Tech Specs

Angio-Seal™ Evolution™

Ordering Information   View Catalog   

Contents: Vascular Closure Device, Insertion Sheath, Arteriotomy Locator and 70 cm Guidewire with “J” Straightener (10 units per box)

Reorder Number French Size Guidewire Diameter (in)
C610134 6 0.035
C610135 8 0.038

How It Works

Product Demonstration

Angio-Seal Evolution, is designed to deliver consistent collagen compaction, overcoming user variability to create a superior seal. Watch this product demonstration to understand how the latest platform of Angio-Seal is revolutionizing vascular closure.

 

Watch the video to the right and then scroll down to see Step-by-Step Instructions on using Angio-Seal Evolution. 

Length: 02:45
This video is presented without sound.

Step-by-Step Instructions

Locate the Artery

Locate the Artery

Exchange procedure sheath with Angio-Seal Locator System.

  1. Blood flow through the locator confirms sheath has entered the artery.
  2. Confirm proper location by withdrawing and reinserting the Angio-Seal locator system until blood flow resumes and then STOP.
  3. Remove locator and wire, leaving the sheath in place.
Set the Anchor

Set the Anchor

  1. Carefully grasp the Angio-Seal device just behind the Bypass Tube and slowly insert into the sheath until you hear a click.
  2. Maintain a grip on the Sheath Hub, grasp Device Handle, and gently pull back until you hear another click.
Seal the Puncture

Seal the Puncture

  1. Provide support to the puncture site with two fingers.
  2. Gently pull back on the Angio-Seal Device Handle along the angle of the puncture tract.
  3. Continue to pull back until hemostasis is achieved. As a guide, the colored compaction marker will be revealed.
Release the Suture

Release the Suture

  1. Release and hold down the Suture Release Button.
  2. Gently pull back on the device handle until the suture is exposed.
  3. With tension on the suture, cut the suture below skin level.

For more information related to Angio-Seal please visit the following sites:

The Knowledge Center is an online resource for interventional cardiologists. The website provides a complete collection of education materials related to PCI optimization - Fractional Flow Reserve and Optical Coherence Tomography - as well as Access and Closure. 

Clinical Discoveries provides background information on clinical challenges and research. It also provides access to clinical resources, such as downloadable PowerPoint presentations and publications.


MATERIALS & LINKS

Indications, Safety & Warnings
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Rx Only

Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

St. Jude Medical Angio-Seal™ Vascular Closure Device product family, including the STS Plus, VIP and Evolution platforms, is 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 using an 8 French or smaller procedural sheath for the 8F Angio-Seal™ device and a 6 French or smaller procedural sheath for the 6 F Angio-Seal™ device. The Angio-Seal™ STS Plus, VIP and Evolution platform devices are also indicated for use to allow patients who have undergone diagnostic angiography to safely ambulate as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to safely ambulate after sheath removal and device placement. Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation, or edema.

Last Updated: May 9, 2014