Ablation Catheters for Atrial Fibrillation Approved
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).