Eclipse Surgical TMR Laser Shipments Commence Following FDA Approval
This article was originally published in The Gray Sheet
Executive Summary
Shipments of Eclipse Surgical Technologies' Eclipse 2000 transmyocardial revascularization laser system began "immediately" following FDA approval, announced Feb. 11, at a price of $295,000 each, according to the firm.
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Eclipse Surgical Technologies, Inc.
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"
Eclipse Surgical Technologies, Inc.
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"
Eclipse Surgical Technologies
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