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U.S. Department of Health and Human Services

Medical Devices

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7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System - P020045

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: 7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System
Manufacturer: CryoCath Technologies Inc.
Address: 16771 Chemin Ste Marie Kirkland, Quebec, Canada H9H 5H3
Approval Date: April 17, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p020045a.pdf

What is it? “Cryo” refers to very low or cold temperatures. “Ablation” refers to the destruction or removal of something. A cryoablation catheter is a long, thin flexible tube that delivers pressurized refrigerant (cold liquid) to a specific location inside the heart. This is done to treat abnormal heart beats (cardiac arrhythmias) due to the loss of the normal rhythm of the heart.

For a labeled drawing of the heart: http://www.nlm.nih.gov/medlineplus/ency/article/003795.htm#visualContent

How does it work? The Freezor® Catheter is inserted through a small cut in the skin and inserted into a blood vessel that leads to the heart. The catheter is then advanced through the vessel into the heart. The end of the catheter is placed against the inside of the heart in the area causing the abnormally fast heart beat. The control console then supplies cold liquid under pressure to the catheter tip in the heart. This causes the catheter tip touching the heart tissue to become very cold. The cold temperature “ablates” or destroys the tissue causing the abnormal heart beat and the cold liquid goes back to the console.

When is it used? The Freezor® Catheter is used to destroy small areas in the heart that cause an abnormally fast heart beat in the upper chambers (the atria) of the heart. The technical name for this kind of abnormal heart beat is “SVT” (supraventricular tachycardia), or more specifically, “AVNRT” (atrioventricular node re-entry tachycardia).

What will it accomplish? It can cure the kind of fast heart beat (or heart rate) called AVNRT.

When should it not be used? It should not be used when the patient has:

  • a blood clot in the heart,
  • an infection in the heart,
  • an artificial mitral heart valve (valve that separates upper and lower chambers on left side of heart), or
  • a blood condition where certain blood proteins precipitate (come out of a solution) at low temperatures (cryoglobulinemia).

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020045