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U.S. Department of Health and Human Services

Medical Devices

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Therapy™ Cool Flex™ Ablation Catheter and IBI 1500T9-CP v.1.7 Cardiac Ablation Generator - P110016/S008

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Picture of the device.

Product Name:  Therapy™ Cool Flex™ Ablation Catheter and IBI 1500T9-CP v.1.7 Cardiac Ablation Generator
PMA Applicant:
Irvine Biomedical, Inc., A St. Jude Medical Company
Address: 
2375 Morse Ave., Irvine, CA 92614
Approval Date:  
December, 18, 2013
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs /pdf11/P110016s008a.pdf

What is it?  The Therapy Cool Flex Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia) called typical atrial flutter by finding the source of the rhythm disturbance and destroying (ablating) small areas of the heart tissue. The catheter takes energy from an external source (the IBI1500T9-CP V1.7 Cardiac Ablation Generator) to a point in the right side of the heart.  The Therapy™ Cool Flex™ Ablation Catheter has a laser-cut electrode tip which is different than the previous model of the device. The laser-cut pattern allows the tip to be flexible and provides a more uniform distribution of saline fluid to the ablation site.

How does it work?  The Therapy Cool Flex Ablation Catheter is inserted into a blood vessel (artery or vein), usually though a site in the upper leg or neck. The catheter is manually advanced through increasingly larger blood vessels until it reaches the correct location inside the heart. The tip of the catheter can be made into a curve or straightened out by pushing or pulling the handle. This allows the tip of the catheter to reach different areas inside the heart. Once inside the heart, electrodes at the tip of the catheter gather data that identify the location of the faulty tissue in the heart (electrical mapping). Once the site is identified, the device delivers radiofrequency (RF) energy to destroy the small areas of tissue that block the heart's internal electrical signals that cause the typical atrial flutter. The catheter is removed after treatment.

When is it used? The Therapy Cool Flex Ablation Catheter and the IBI 1500T9-CP V1.7 Cardiac Ablation Generator are used to destroy small areas in the heart that cause an abnormally fast heart beat or abnormal heart rhythm in the upper chambers (the atria) of the heart. The technical name for this kind of abnormal heart beat is typical atrial flutter.

What will it accomplish? Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm. In other cases, it can reduce the frequency of episodes that a patient experiences. In a clinical study involving 179 patients, the abnormal rhythm (typical atrial flutter) was corrected in 177 patients (98.8%) at least 30 minutes after treatment; and it remained corrected after 3 months in 150 patients.

When should it not be used?  The device should not be used in patients:

  • who have an active systemic infection.
  • with a blood clot attached to the inside of the heart.
  • who have had an incision in the atrium or ventricle in the last 4 weeks.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.