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.