Cardiogenesis trials
This article was originally published in The Gray Sheet
Executive Summary
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)...