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Percutaneous Myocardial Laser Developer Drafts IDE Agreement With FDA

This article was originally published in The Gray Sheet

Executive Summary

CardioGenesis will meet with FDA by year-end to finalize a clinical trial protocol to support PMA approval of its Axcis laser percutaneous myocardial channeling (PMC) system for treating severe angina

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Cardiogenesis trials

Foothill Ranch, Calif.-based company submits IDE application to FDA to conduct trials supporting angina treatment indication for percutaneous myocardial channeling (PMC) system, the firm announces July 6. Cardiogenesis secured an agreement from FDA in June on key aspects of the trial design, endpoints and patient criteria for the study protocol. The company plans to leverage data from an Axcis PMC device rejected by FDA in 2001 (1"The Gray Sheet" Nov. 22, 2004, p. 14)...

Cardiogenesis trials

Foothill Ranch, Calif.-based company submits IDE application to FDA to conduct trials supporting angina treatment indication for percutaneous myocardial channeling (PMC) system, the firm announces July 6. Cardiogenesis secured an agreement from FDA in June on key aspects of the trial design, endpoints and patient criteria for the study protocol. The company plans to leverage data from an Axcis PMC device rejected by FDA in 2001 (1"The Gray Sheet" Nov. 22, 2004, p. 14)...

CardioGenesis Prepares For New Trial Of Percutaneous Laser Angina Device

CardioGenesis credits the recent regulatory progress of its Axcis laser percutaneous myocardial channeling (PMC) system to the contributions of Syncardia CEO Marvin Slepian, MD

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