In Brief: Guidant
This article was originally published in The Gray Sheet
Executive Summary
Guidant: Advanced Cardiovascular Systems unit receives approval of an investigational device exemption for its ACS RX Multi-Link rapid exchange "low profile, sheathless" coronary stent delivery system. Clinical trials "will begin immediately" in conjunction with Guidant's ACS Multi-Link coronary stent, which entered U.S. trials in August 1995 ("The Gray Sheet" Sept. 4, 1995, p. 7). The Rx delivery system was launched in Europe earlier this year. Separately, Guidant announces FDA clearance of its AtheroCath Bantam, the latest generation of its AtheroCath directional coronary atherectomy catheters...