Angio-Seal

Angio-Seal - All An Angio-Seal is a device used to close the puncture in your femoral artery. Most commonly, the application of weight by hand or a clamping device is used to stop the bleeding, but this method is slow and can be uncomfortable. The Angio-Seal procedure takes a fraction of the time, and bleeding stops much more rapidly with little or no compression. A small anchor is placed into the artery and used to seal the puncture. The anchor is drawn together with a collagen sponge by a suture, and the suture is then cut at the skin level. The Angio-Seal completely absorbs into your body within 90 days. Before leaving the hospital, be sure to discuss care of the catheterization site and safe activity levels with your doctor or nurse. You will also be given a Patient Information Card to carry with you for the next 90 days.

Introduction

Why an Angio-Seal® device to close the puncture in my femoral artery?

Your doctor has chosen a device called the Angio-Seal to close the puncture in your femoral artery.

Most commonly, the application of weight by hand or a clamping device is used to stop the bleeding. This method is slow and can be uncomfortable. It also requires at least 15 minutes of compression followed by 4 to 8 hours of lying flat in bed without moving the affected leg.

However, patients report that the Angio-Seal procedure itself takes a fraction of the time and the bleeding stops much more rapidly with little or no manual compression.


How Does The Angio-Seal Device Work?

The Angio-Seal device is made of three absorbable components:
  1. A small anchor


  1. A collagen sponge, and


  1. A suture


The anchor is placed into the artery through a small delivery system where it is pulled against the inside wall of the artery to seal the puncture.

The Angio-Seal device anchor and collagen sponge are drawn together with the suture. A small plastic tube and metal tension spring are used to maintain consistent pressure, closing the hole and securing the seal.

The small plastic tube is used to maintain consistent pressure on the collagen sponge and is then removed 20 minutes later.

The absorbable suture is subsequently cut at the skin level. The suture, still attached to the anchor and collagen sponge, retracts below the skin surface and permits the healing process to begin.

A sterile dressing is then applied to the site.

Within 60 to 90 days the anchor, collagen sponge and suture will naturally be absorbed by your body.


What Should I Discuss With My Doctor Or Nurse Before Leaving The Hospital?

Before you leave the hospital, discuss with your doctor the appropriate care of your catheterization site and the level of activity you can participate in post-discharge.

Additionally, notify your physician or nurse if you have any of the following conditions
  • Allergy to absorbable suture, beef products and/or collagen products.


  • Uncontrollable high blood pressure.


  • Circulation problems or previous vascular surgery in leg arteries.


  • Pregnancy or lactation.


  • Autoimmune disease.



What Can I Expect When I Go Home And When Should I Call My Doctor?

This device has been proven safe and effective in clinical trials.

Some bruising or discomfort, however, is common during the healing process after intravascular procedures.

Your doctor will give you a Patient Information Card. Carry this card with you in your wallet for the next 90 days.

If you experience persistent tenderness in the groin area, bleeding, swelling, wound drainage, numbness or tingling in the leg, fever, redness, warmth, or bruising at the puncture site, or any other unusual observation, please contact your doctor or nurse immediately at the number listed on your Patient Information Card.


What Happens If I Need Another Procedure Using The Same Femoral Artery Within The Next 90 Days?

The Angio-Seal Device is completely absorbed in 90 days.

If you have another procedure within 90 days of the first, inform your doctor you received an Angio-Seal Device and provide the doctor with your Patient Information Card. This information will help your doctor determine subsequent treatment.


Summary

Your doctor has chosen a device called Angio-Seal to close the puncture in your femoral artery.

By using the Angio-Seal device, the bleeding from your puncture site stops much more rapidly than with manual compression.

The Angio-Seal Device will be naturally absorbed by your body.


 

Last modified: August 22, 2011