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TMR Post-Market Study Should Evaluate Long-Term Efficacy - FDA Panel

This article was originally published in The Gray Sheet

Executive Summary

Postmarket surveillance of PLC Medical's Heart Laser transmyocardial revascularization (TMR) device should address the long-term reproducibility of its safety and efficacy and further assess mortality associated with the system, FDA's Circulatory System Devices Panel recommended April 24 at its meeting in Gaithersburg, Maryland.

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Edwards LifeSciences' agreement to become the exclusive distributor of PLC Medical Systems' next-generation transmyocardial revascularization system, announced Jan. 9, demonstrates the Baxter spin-off's belief in the validity of a technology that has yet to be fully embraced by the market.

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