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Eclipse Surgical Technologies

This article was originally published in The Gray Sheet

Executive Summary

Data are submitted to FDA in support of market clearance for catheter-based percutaneous transluminal myocardial revascularization (PTMR) by interventional cardiologists. The company received FDA approval for open-chest transmyocardial revascularization using the Eclipse TMR 2000 solid-state laser system in February 1999 (1"The Gray Sheet" Feb. 15, 1999, p. 3). The PTMR submission includes 12-month data from a randomized, controlled multi-center study comparing PTMR to drug therapy in patients with severe angina and no other procedural options

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