PROGRESSIVE ANGIOPLASTY SYSTEMS ACT-ONE NITINOL STENT SLATED FOR U.S. TRIALS IN COMING MONTHS; GLOBAL THERAPEUTICS' STENT IDE PLANNED FOR 3RD Q.
This article was originally published in The Gray Sheet
Executive Summary
Progressive Angioplasty Systems expects to submit an investigational device exemption application to FDA during the week of April 1 for its ACT-One balloon-expandable coronary stent. Data from the planned IDE clinical study of the radiopaque nitinol device will support a premarket approval application that the company hopes to submit by late 1997.