Cardiovascular Systems, a US-based medical device company, has obtained a premarket approval from the US Food and Drug Administration (FDA) for its Diamondback 360 coronary orbital atherectomy system (OAS), designed to treat severely ...
Cardiovascular Systems has completed enrolling 443 patients in the ORBIT II trial of its electric orbital atherectomy system(OAS),designed to treat severe calcified coronary arteries. The first premarket approval(PMA)trial,which is ...
Tags: cardiovascular system, OAS, severe calcified coronary arteries, ORBIT II