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Back To Vidyya FDA Approves Two New Devices To Help Reduce The Risk Of Repeat Coronary Stent Restenosis


Regarding The Safety Of Phenylpropanolamine

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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Editor: Susan K. Boyer, RN
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