Haemonetics Corporation's CardioPAT surgical blood salvage system has received 510(k) marketing clearance by the US FDA. The CardioPAT system allows surgeons to recover blood lost by a cardiovascular surgery patient during and after the surgery, and make the blood available for transfusion back to the patient. The process, known as surgical blood salvage or autotransfusion, ensures that a patient is transfused with the safest blood possible, his or her own.
According to the release, the Cell Saver brand is Haemonetics' flagship product platform that created and leads the surgical blood salvage market. The CardioPAT system broadens further Haemonetics' cell salvage product portfolio by adding a device with enhanced functionality that makes the new product ideally suited for providing autotransfusion to the off-pump, or beating heart cardiovascular surgery.
Specifically, the CardioPAT system can salvage blood lost both in the operating room and during recovery in the post-operative intensive care unit. Additionally, the system combines the excellent blood processing capability that is the hallmark of Haemonetics' cell salvage devices with a product platform that is small, mobile, easy to use and electronically monitors post-operative blood loss, the release added.
Haemonetics estimates that approximately 20 per cent of annual coronary artery bypass graft (CABG) surgeries use the off-pump surgical technique, representing a $120-million global market for the CardioPAT system. Haemonetics will begin customer acceptance trials at three US sites immediately. Full market release is expected in 2005.
Brian Concannon, president of Haemonetics' Patient Division, said, "The CardioPAT system is exciting technology which leverages the Dynamic Disk used in our OrthoPAT system to give us a unique product with no perioperative competition in the growing market of beating heart surgeries."
Haemonetics began customer acceptance trials of the CardioPAT system in Europe in the last quarter of calendar 2004. The CardioPAT system performed very well and staff at the trial sites are enthusiastic about the device.
Dr. Andrew Owens, Clinical Director of Cardiothoracic Surgery at The James Cook University Hospital, U.K said, "This is a very exciting technique that will have compelling benefits for heart patients. I anticipate that other cardiac centres will adopt the CardioPAT for routine use with cardiac patients especially as the transition from intra-operative to post-operative intensive care is simplified with the CardioPAT system. With this device, ICU staff have greater opportunity to enhance patient care by providing the system perioperatively."
Haemonetics is a global company engaged in the design, manufacture and worldwide marketing of automated blood processing systems.