FDAnews
www.fdanews.com/articles/67428-orqis-medical-cleared-to-expand-trial-of-cancion-crs-system

ORQIS MEDICAL CLEARED TO EXPAND TRIAL OF CANCION CRS SYSTEM

January 11, 2005

The FDA has approved an expansion of Orqis Medical's clinical trial for the Cancion CRS therapy, a percutaneous cardiac recovery system being evaluated for its ability to reverse the consequences of abnormal aortic flow, induce vasodilatation and improve renal blood flow

Through the use of a blood pump and peripheral access to the circulatory system, the Cancion CRS system increases blood flow in the descending aorta without taking over the function of or requiring synchronization with the heart, and without ever touching it.

The clinical trial will be expanded from eight to 40 medical centers throughout the U.S., and also will focus on hemodynamic improvement, reduced ventricular and atrial volumes, improved renal function and whether the Cancion CRS may have a sustained effect after removal.