FDA Nixes Heart-Surgery Device
A US Food and Drug Administration panel has rejected by a vote of 9-2 the use of a device to treat end-stage heart disease. The procedure, known as transmyocardial revascularization, involves piercing holes in the heart wall with a laser.
The proposed laser system, from PLC Systems Inc. of Franklin, Mass., is designed as an option to chronic chest pain sufferers who do not respond to angioplasty or coronary artery bypass surgery. FDA panelists criticized the company for incomplete trial data and for its limited understanding of how the laser procedure restores blood flow to damaged heart tissue.
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