Boston's coronary stent trials halted in Europe

25 April 2001

In Europe, Boston Scientific has halted the enrollment of patients inclinical trials of its QuaDS-QP2 paclitaxel-coated coronary stent, made by its recently-acquired Quanam Medical division, in patients undergoing revascularization procedures, due to negative heart-related events in the trial.

Boston Scientific said that doctors were not following study guidelines when they installed some stents and that the medications given to patients in the study were not prescribed correctly or taken properly. This, the company said, has probably contributed to the heart problems experienced.

The enrollment of patients had been suspended even before Boston Scientific's acquisition of Quanam in February, when officials had said that they were reviewing the study. The company plans to continue following patients who did not experience adverse cardiac events to the stents, saying that these patients demonstrated promise for the future of the product.

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