FDA moving forward to approve vascular brachytherapy system

[Chris Alston <alstonc@odrge.odr.georgetown.edu>]

>From: "Jacobus, John (OD)" <JJacobus@ORS.OD.NIH.GOV>
>July 6, 2000
>
>VASCBRACHYGRAM
>
>
>Vascular brachytherapy using gamma radiation (Ir 192) is a step closer to
>pre-market approval by the Food and Drug Administration (FDA).
>
>The FDA Circulatory System Devices Panel has voted to give pre-market
>approval to the Cordis CHECKMATE system.  The panel, which is advisory to
>the FDA, unanimously approved the system.  The panel listed specific
>conditions, including the requirement for a multidisciplinary team, that
>must be met for use of the device.  The FDA is now reviewing the panel's
>recommendation.  If it is approved by the FDA, it will be commercially
>available for use in coronary in-stent restenosis. A decision is expected
>soon.
>
>Recently, Novoste Beta-Cath System, using Sr/Y90, applied for FDA pre-market
>approval.  A decision is expected early in 2001.
>
>        ASTRO's fall symposium will focus on vascular brachytherapy and the
>integration of the procedure into clinical practice.  The session, to be
>held September 23 at the New York Hilton and Towers, New York, NY will
>outline treatment planning and dosimetry.  An overview of completed and
>ongoing clinical coronary clinical trials as well as peripheral vascular
>clinical trials will be presented.  Practical issues relating to the
>development of a vascular brachytherapy program into a radiation oncology
>department will be noted.  Reimbursement issues also will be discussed.
>
>For further information, including registration information, log onto
>www.astro.org.
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