UPDATE – MAQUET Cardiovascular Receives 510(k) Clearance to Market the CARDIOHELP System in U.S.
WAYNE, N.J., May 12, 2011 /PRNewswire/ — Jeremy Cannon, M.D., trauma surgeon at Brooke Army Medical Center in San Antonio, Texas, has issued a modified statement surrounding MAQUET Cardiovascular’s recent announcement on April 28, 2011, that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its CARDIOHELP System in the United States as a cardiac and/or respiratory assist device for up to six hours.
“The ability to bring environmental control and life support equipment on every run for inter-hospital transport could truly enable centralized care of the most critically ill respiratory failure patients and others as ECLS applications are explored further,” said Dr. Cannon.*
The CARDIOHELP System is the world’s smallest portable heart-lung support system providing extracorporeal life support (ECLS) to replace or support a patient’s circulation and respiration. The product is expected to be commercially available in the United States later this year.
*The opinions expressed by Dr. Cannon are solely his own and do not represent an endorsement by or the views of the United States Air Force, the Department of Defense, or the United States Government.
SOURCE MAQUET Cardiovascular