Trimedyne
This article was originally published in The Gray Sheet
Executive Summary
Plans to submit an investigational device exemption application to FDA "in late 1993" for clinical trials of "a new advanced family of laser catheters" that will "more effectively vaporize" arterial plaque, according to a July 19 release. The laser catheters are designed "to create a channel significantly larger than their diameter and restore normal blood flow, without the need to follow the laser procedure with balloon angioplasty," the firm says. Trimedyne recently acquired a patent covering the catheter technology from Robert Ginsburg, MD, University of Colorado; terms were not disclosed.