Cardiogenesis’ Phoenix TMR plus biologic
This article was originally published in The Gray Sheet
Executive Summary
Phoenix gains CE mark approval, enabling a "controlled" European launch, the firm announces Oct. 10. The advanced combination delivery system administers Cardiogenesis' transmyocardial revascularization laser treatment in conjunction with biologic therapy, such as autologous bone marrow stems cells, for advanced coronary artery disease not treatable with bypass surgery. Initial clinical data, along with ongoing research, will help determine "the appropriate regulatory, reimbursement and commercial strategies in the U.S.," the firm states. The combination Ho:YAG laser energy/biologic delivery system also can be used with drugs, according to Cardiogenesis...