Haemonetics' redesigned cardioPAT surgical blood salvage system has received marketing clearance from the FDA. The system allows surgeons to recover blood lost from a cardiovascular patient during and after surgery and makes it available for transfusion back to the patient.
The company estimates that cardioPAT is the only autotransfusion product in the growing beating heart surgeries market.
The cardioPAT system originally received FDA approval in January 2005, but in July Haemonetics voluntarily recalled the 30 devices at customer trial sites after it discovered a potential problem with a valve on the disposable. Brian Concannon, President of Haemonetics' Patient Division, said, "Consistent with our expectations, we were able to quickly obtain regulatory clearance for our improvements. We are currently conducting new customer acceptance trials and remain on schedule for market release of the cardioPAT system in early calendar 2006."
Despite the early product difficulties, cardioPAT received the 2005 Medical Design Excellence Award, given by Canon Communications in April. Haemonetics estimates that approximately 20% of annual coronary artery bypass graft surgeries use the off-pump surgical technique, representing a potential $120 million global market for the cardioPAT system.
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