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Eclipse Surgical Technologies.

This article was originally published in The Gray Sheet

Executive Summary

Independent data and safety monitoring committee determines that the firm will not need to enroll additional patients in its clinical trial for transmyocardial revascularization performed in conjunction with coronary artery bypass graft surgery. Data show "eight times fewer early deaths" in the TMR/bypass group when compared to bypass surgery alone, the firm claims. Eclipse, which plans to submit either a premarket approval application or PMA supplement for use of its holmium laser for use in conjunction with bypass surgery, is "seeking the FDA's guidance on how to proceed." A pending PMA for its laser as sole treatment for patients believed to have no surgical option was submitted in July 1997 ("The Gray Sheet" July 14, In Brief)...

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