Medical Device Safety and Recalls: FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication

FDA has recently posted a safety communication titled, "FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction." The purpose of this communication is to alert audiences about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use.

 

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