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New Device Approval

EVS™ Vascular Closure System - P040022

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: EVS™ Vascular Closure System
Applicant: angioLINK Corporation
Address: 125 John Hancock Road, Suite Six, Taunton, MA 02780
Approval Date: November 3, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040022a.pdf

What is it? The EVS™ Vascular Closure System is used to stop bleeding following diagnostic and interventional heart (cardiac) catheterization procedures. After a cardiac catheterization procedure it is necessary to stop the bleeding in a blood vessel in the leg (the femoral artery). The EVS™ System uses a titanium staple to stop bleeding by closing the hole in the artery.

During a cardiac catheterization procedure:

• A needle is used to make a small tunnel through the skin and tissue and into the femoral artery.
• A thin, flexible, hollow tube (catheter) is threaded through the blood vessel until it reaches the heart.
• The catheter is used to carry specialized tools and medicines for the diagnosis and treatment of heart disease.
• The catheter is removed and the EVS™ System is used to staple the hole in the femoral artery closed.

How does it work?

• Following the cardiac catheterization procedure, a guidewire is reintroduced through the introducer and the introducer sheath is removed.
• The hole (arteriotomy) is then closed by advancing the EVS™ System over the guidewire through the skin and soft tissue into the arteriotomy.
• Once positioned, the dilator and guidewire are removed from the introducer and the stapler is advanced through the introducer and locked into place.
• The staple is deployed by squeezing the trigger and the device is removed.

When is it used? The EVS™ System is used following a cardiac catheterization procedure. For a picture of a cardiac catheterization, use the following link: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1080.htm

What will it accomplish? The EVS™ System is an alternative to applying manual pressure (compression) to the puncture site to stop bleeding. The EVS™ System uses a titanium staple to close the hole in the femoral artery and stop bleeding. The EVS™ System allows patients to get out of bed and walk sooner than is possible with standard compression methods.

When should it not be used? There are no contraindications for the use of this device.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040022.html

Other:

• Cardiac catheterization information:
  http://www.nlm.nih.gov/medlineplus/ency/article/003419.htm
• Left side of heart catheterization information:
  http://www.nlm.nih.gov/medlineplus/ency/imagepages/18143.htm
• HeartHealth Online:
  http://www.fda.gov/hearthealth
• Diet information and links to other government sites with heart information:
  http://www.cfsan.fda.gov/~dms/wh-heart.html

Updated November 8, 2004

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