MAQUET Cardiovascular Receives 510(k) Clearance to Market the CARDIOHELP System in U.S.
WAYNE, N.J., April 28, 2011 /PRNewswire/ -- MAQUET Cardiovascular today announced 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 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.
"Cardiovascular disease is the leading cause of death globally, with an estimated 17.5 million deaths each year," said Jeremy Cannon, M.D., trauma surgeon at Brooke Army Medical Center in San Antonio, Texas. "Many of these individuals experience cardiogenic shock because vital organs are not adequately supplied with oxygen. By quickly connecting a patient to a cardiopulmonary support system, the CARDIOHELP System will allow clinicians to gain valuable time that could save the patient's life*."
The CARDIOHELP System, which includes the HLS Advanced Tubing Set, is the first support system approved for both ground and air transportation.** It is light enough to be carried by one person and compact enough to be transported in a helicopter or vehicle. With its disposables, integrated sensors and individual operating modes, the CARDIOHELP System provides new options for patients whose heart and/or lungs are failing despite other treatment options.
"The need for immediate, mobile, compact, life-sustaining resuscitation occurs on a daily basis, both in and outside the hospital," said Linda Mongero CCP, perfusionist at New York Presbyterian Hospital. "CARDIOHELP is a collective system of engineering that finally optimizes cardiopulmonary support in prime time."
"The FDA clearance of the CARDIOHELP System means that we can provide clinicians and rapid response tea