Intravascular Brachytherapy Cleared by FDA

Data from an animal study presented at the European Society of Cardiology in Amsterdam showed support for the antiproliferative effect of the drug.

A massive international trial called PRESTO (Prevention of Restenosis with Tranilast and its Outcomes) enrolling 11,500 patients at more than 450 medical centers in 17 countries is seeking to determine if tranilast can reduce the major adverse events associated with restenosis, such as death, heart attack, and the need for revascularization. All trial patients have completed the treatment phase of the trial. Followup evaluation will continue for another six months. Some patients are being evaluated by angiography while others are being evaluated by intravascular ultrasound.

Tranilast is being developed by SmithKline Beecham (SB, Philadelphia, PA, USA) under license from Kissei Pharmaceutical Co., Ltd. (Tokyo, Japan). "The size and scope of the PRESTO reflects our specific commitment to providing a new treatment option to prevent restenosis and our overall commitment to making significant contributions to the field of cardiology,” said Neil Shusterman, M.D., vice president and director of the cardiovascular therapeutic unit at SB.




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