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T00-59                     Print Media:         301-827-6242
November 6, 2000           
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FDA APPROVES TWO NEW DEVICES TO HELP REDUCE THE RISK OF REPEAT CORONARY STENT RE-NARROWING (IN-STENT RESTENOSIS)

FDA today approved two new devices that administer radiation energy for treatment of in-stent restenosis. These types of devices, called intravascular brachytherapy systems, are the first of their kind.

Coronary artery narrowing producing cardiac chest pain symptoms (angina) is a frequently encountered problem in the U.S. Approximately 700, 000 patients per year have their symptoms treated by placement of a coronary stent in the narrowed artery. A stent is a metallic device that acts as a scaffold to hold the artery open at the site of the blockage.

The majority of patients who receive a coronary stent have complete resolution of their symptoms. A minority of patients, however, develops a re-narrowing within the stent, due to an exaggerated healing response within the stented area. The new re-narrowing is called in-stent restenosis and has proved to be very difficult to treat with currently available medical devices.

After initial opening of the in-stent restenosis blockage with a balloon catheter (PTCA), the brachytherapy device is temporarily placed at the site of the in-stent restenosis. The radiation treatment prevents an exaggerated healing response at the lesion site and a recurrence of a significant blockage.

In clinical studies the two brachytherapy devices were shown to be safe and effective in reducing the need for additional procedures for treatment of in-stent restenosis. Adverse reactions associated with use of radiation are minimized with appropriate drug treatment.

The two newly approved devices are the Cordis Checkmate™ System sponsored by Cordis Corporation of Miami, Florida and the Novoste Beta- Cath™ System sponsored by the Novoste Corporation of Norcross, Georgia.

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