ANGIO-SEAL® EVOLUTION™ Vascular Closure Device

PRODUCT OVERVIEW

ACTIVE CLOSURE SYSTEM

Designed to hold the solution in place, the active closure system consists of an innovative intra-arterial anchor, suture and collagen seal that are fully bioabsorbable within 60 to 90 days.1

DEVICE COMPONENTS

ANGIO-SEAL EVOLUTION ANIMATION

STEP-BY-STEP INSTRUCTIONS2

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

  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

  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

  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.

PRODUCT CODES

Angio-Seal Evolution

Part Number

French Size

Guidewire Diameter (in)

C610134 6Fr .035 Wire
C610135 8Fr .038 Wire

DOCUMENTS

ANGIO-SEAL Core Brochure
ANGIO-SEAL Core Brochure
Angio-Seal Evolution IFU
Angio-Seal Evolution IFU
Angio-Seal Evolution Deployment Guide
Angio-Seal Evolution Deployment Guide

REFERENCES

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use. 

  1. Nash JE, Evans DG. The Angio‐Seal hemostatic puncture closure device. Concept and experimental results. Herz. 1999; 24(8), 597‐606.
  2. ANGIO-SEAL® EVOLUTION Instructions for Use, TMC600006626 Revision 2017-01.

Indications:
The  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 of 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 8 F 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.

Important Safety Information:
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. This device should only be used by a licensed physician (or other health care professional authorized by or under the direction of such physician) possessing adequate instruction in the use of the device, e.g., participation in an Angio-Seal physician instruction program or equivalent.