Ablation Catheters for Atrial Fibrillation Approved

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  • February 13, 2009
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The U.S. Food and Drug Administration (FDA) announced, Feb. 6, that it has approved the first ablation catheters—BioSense Webster’s NaviStar ThermoCool and the EZ Steer ThermoCool Nav—for the treatment of atrial fibrillation (AF).

Atrial fibrillation (uncoordinated contraction of the upper heart chambers) is one of the most common types of arrhythmias (abnormal heart rhythms), affecting an estimated 2.2 million Americans, according to the American Heart Association. AF is generally diagnosed with the assistance of an electrocardiogram (EKG) and a comprehensive examination of a patient’s symptoms.
A patient with AF may present with symptoms such as palpitations, syncope, spells of lightheadedness, chest pains, or symptoms of congestive heart failure.
AF is usually treated with drugs—most commonly anti-coagulants such as Warfarin or Coumadin in addition to aspirin. The FDA advises only to use catheter ablation after drug treatment has failed to adequately control symptoms.
NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav can be used to create small, strategically placed scars in heart tissue to block irregular electrical waves that cause AF.
Approval was based on a clinical study of 167 patients at 19 medical centers in the United States, Brazil, Canada, the Czech Republic, and Italy. Data from the study showed the devices were effective in eliminating symptomatic recurrence of AF episodes for one year in approximately 63 percent of treated patients (FDA).

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No Responses to “Ablation Catheters for Atrial Fibrillation Approved”

  1. pricilla brewster says:

    It is a Blessing to be updated on new information involving heart diseases resolutions.
    People should be educated about new findings on medical issues.

  2. Sharon says:

    My husband is a sufferer of AFib and is currently stable on his oral medication. He was set up to under go a cardiac Ablation late last year and after much thought and sole searching we decided as a team to just stay the course with is medications until the need arises for an type of invasive intervention. Thank God for great drugs. Even being a nurse, the whole procedure of killing parts of the heart that is causing the problems scared me to death. But I am glad to know that if in the future anything needs to be done, that at least there is going to be new and better emerging technology around if/when he needs it.