In Brief: Eclipse Surgical
This article was originally published in The Gray Sheet
Executive Summary
Eclipse Surgical: Amends pending premarket approval application for use of the TMR transmyocardial revascularization laser system to treat patients with severe angina caused by coronary artery disease. The original PMA was submitted July 1 ("The Gray Sheet" July 14, In Brief). The amendment includes 12-month follow-up data from a Phase II randomized, controlled study comparing TMR to drug therapy for Class IV angina patients who had no other surgical options...