In Brief: InterVentional Technologies
This article was originally published in The Gray Sheet
Executive Summary
InterVentional Technologies: Firm's TOPIT (TEC or PTCA in Thrombus) study is halted following an interim analysis of results from 250 patients. The study, intended to include 550 patients, was comparing the frequency of "major in-hospital complications" in acute ischemic syndrome patients treated with extraction atherectomy using IVT's TEC device to patients treated via conventional percutaneous transluminal angioplasty. According to IVT, the study's primary investigator William O'Neill, MD, concluded that the trial should be stopped because "patient safety was very significantly compromised in the treatment arm that excluded the use of TEC." Data from TOPIT are scheduled to be presented Nov. 12 at the American Heart Association scientific sessions in New Orleans...