Cardiogenesis Announces Binding LOA for PMC Clinical Trial

Cardiogenesis, a company specializing in surgical products and accessories used in angina-relieving transmyocardial revascularization and percutaneous myocardial channeling (PMC) procedures, announced it has received a binding letter of agreement (LOA) from the FDA regarding the trial design for its PMC system. The company plans to submit the investigational device exemption application to the FDA by June 30 and begin this trial on patients suffering from severe angina soon after approval.

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