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Eclipse Surgical Technologies, Inc.

This article was originally published in The Gray Sheet

Executive Summary

Company elects to bypass pursuit of an expanded indication for the Eclipse TMR 2000 transmyocardial revascularization solid-state laser system for use in conjunction with coronary artery bypass grafting following a review of its regulatory strategy, announced March 15. The device was approved for TMR alone in February 1999 (1"The Gray Sheet" Feb. 15, 1999, p. 3). "FDA approved labeling is adequate," Eclipse says, and "the physician can best decide how to use the laser system within the approved labeling." A 263-patient randomized study published in the March issue of the Journal of Thoracic and Cardiovascular Surgery comparing the combination therapy to CABG alone showed "angina relief and exercise treadmill improvement were indistinguishable between groups at 12 months of follow-up"
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