This article was originally published in The Gray Sheet
Plans to begin a randomized trial in April of its Barath surgical balloon dilatation catheter at ten sites in the U.S., IVT Chairman and CEO Robert Reiss reported Feb. 3 at the fifth annual Piper Jaffray cardiovascular conference in New York City. The device also will be studied in a six-country, non-randomized Phase II trial slated to begin March 1. Phase I trials of 17 patients in the U.S. and 17 patients in Europe have been completed ("The Gray Sheet" Dec. 7, In Brief), and six month followup on ten patients has shown a 0% restenosis rate, Reiss said. IVT hopes to introduce the device in Europe in January 1994.
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