FDA Approves First Laser Device for Heart Surgery

News 02/06/1992 FDA Approves First Laser Device for Heart Surgery
P92-4                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Sharon Snider - (301) 443-3285

    The Food and Drug Administration has approved the first laser device      
designed to open blocked heart arteries of people who are in danger of a      
heart attack.
    The device, the AIS Excimer Laser Angioplasty System, is manufactured by  
Advanced Interventional Systems Inc. of Irvine, Calif.
    The laser is designed for use in heart patients for whom conventional     
balloon angioplasty does not work well, specifically for patients whose       
blockage is unusually long.  The laser opens the artery by vaporizing the     
plaque that blocks it.  Laser angioplasty can be used alone or in             
conjunction with balloon angioplasty.
    Approval was based on a thorough review of safety and effectiveness data  
submitted to FDA by the manufacturer.  A panel of outside experts, who also   
reviewed the data, recommended that FDA approve the device for marketing.
    FDA Commissioner David A. Kessler, M.D., said, "This device will help     
save lives.  It will definitely provide a benefit to heart patients who       
would not do well with balloon angioplasty.  For many of these people         
surgery would have been the only alternative."
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    Clinical studies of 685 patients treated at 18 medical centers showed     
that the device was successful in opening the blocked arteries in 91 percent  
of the cases.  Of patients reevaluated six months later, 56 percent           
continued to have open arteries; 44 percent experienced a re-clogging.
    "It's true that the plaque will re-form in the arteries of many patients  
after the laser treatment," said James S. Benson, director of FDA's Center    
for Devices and Radiological Health, "but when viewed against the very low    
success rate of balloon angioplasty for treating patients with unusually      
long blockage, the success rate of the laser is high enough to warrant its    
use."
    Complication rates with the laser were comparable to those expected with  
balloon angioplasty.
    Although this is the first laser approved by FDA for unclogging heart     
arteries, several other laser devices have already been approved for use in   
opening clogged leg arteries.
    The FDA is one of the eight Public Health Service agencies within HHS.
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