ANGIO-SEAL® VIP Vascular Closure Device

PRODUCT OVERVIEW

BIOABSORBABLE COMPONENTS

The device creates a mechanical seal by sandwiching the arteriotomy between a bioabsorbable anchor and collagen sponge, which dissolve in 60 to 90 days.1

Three bioabsorbable components actively seal the arteriotomy:

  1. Anchor: Bioabsorbable co-polymer anchor placed against the inside of the vessel wall
  2. Collagen: Placed on top of the arteriotomy in the tissue tract
  3. Suture: Cinches the anchor and collagen together to form a secure seal

ANGIO-SEAL VIP CLINICAL DEPLOYMENT VIDEOS

Angio-Seal VIP - Introduction
by Dr. Simon

Angio-Seal VIP - Complete Clinical 
Deployment Procedure

Angio-Seal VIP - Locate Arteriotomy

Angio-Seal VIP - Set Anchor, Seal 
Puncture

ANGIO-SEAL VIP DEPLOYMENT ANIMATION

Angio-Seal VIP - Deployment Animation

STEP-BY-STEP INSTRUCTIONS2

LOCATE THE ARTERY

  1. Exchange the procedure sheath with the Angio-Seal locator system.
  2. Blood flow through the locator visually confirms proper sheath position in the artery.

SET THE ANCHOR

  1. Insert the Angio-Seal VIP device into the sheath until you hear a “click.” 
  2. Gently pull back on the locking cap until you hear another “click.”
  3. The anchor is now locked in place and device is ready to be deployed.

SEAL THE PUNCTURE

  1. Gently pull back on the Angio-Seal VIP device until the suture has stopped spooling.
  2. Maintain upward tension on the device and gently advance the compaction tube until resistance is felt.
  3. Cut the suture and remove the device.

ANGIO-SEAL VIP PRODUCT CODES

Part Number French Size Guidewire Diameter (in)
610130 6Fr .035 Wire
610131 8Fr .038 Wire

DOCUMENTS

ANGIO-SEAL Core Brochure
ANGIO-SEAL Core Brochure
Angio-Seal VIP IFU
Angio-Seal VIP IFU
ANGIO-SEAL Platform Comparison Guide
ANGIO-SEAL Platform Comparison 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. (1999). The Angio‐Seal hemostatic puncture closure device. Concept and experimental results. Herz, 24(8), 597‐606.
  2. Per Instructions For Use ASIN0004 revision 2018-09-01.

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.