The aim of this study was to evaluate the safety and efficacy of coronary orbital atherectomy system Diamondback to prepare de novo lesions severely calcified to stent implantation.

This orbital atherectomy system is the first approved by the FDA to treat this type of injury, so the study had no control group. The rate of revascularization at one year was 5.9%, which is significantly lower than what is written in literature. 

Jeff Chambers
2014-05-20

Title: Coronary orbital atherectomy for treating de novo, severely calcified lesions: 1-year results and economic analysis of the pivotal ORBIT II trial