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In Brief: PLC Systems

This article was originally published in The Gray Sheet

Executive Summary

PLC Systems: Six month follow-up data from transmyocardial revascularization study of 100 patients from 12 U.S. clinical sites shows that firm's Heart Laser reduces angina class compared to medical therapy. TMR reduced average angina class from 3.7 to 1.7; drug therapy increased angina class to 3.9 on average. Mortality in the TMR group was 63% thus far in the TMR group. PLC has used this data and the one-year data from another patient study to "satisfy the FDA's request for premarket data." The firm has a PMA pending at FDA for use of the laser to treat patients without other treatment options...

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