BRAINTREE, Mass., Dec. 8 /PRNewswire-FirstCall/ -- Haemonetics Corporation announced today that the redesigned cardioPAT surgical blood salvage system has received 510(k) marketing clearance by the U.S. Food and Drug Administration. The cardioPAT system allows surgeons to recover blood lost by a cardiovascular surgery patient during and after 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.
The cardioPAT system was originally regulatory-cleared in January 2005, but Haemonetics identified areas for technology improvement during early customer trials and decided to postpone full market release of the technology until those enhancements were incorporated into the system.
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.”
The cardioPAT technology leverages the Dynamic Disk(TM) used in the OrthoPAT(R) system to give a unique product with no perioperative competition in the growing market of beating heart surgeries. The system complements Haemonetics’ extensive autotransfusion product portfolio.
Haemonetics is a global company engaged in the design, manufacture and worldwide marketing of automated blood processing systems. These systems address important medical markets: surgical blood salvage, blood component collection, plasma collection, and blood component safety. To learn more about Haemonetics’ products and markets, visit its web site at http://www.haemonetics.com.
This release contains forward looking statements that involve risks and uncertainties, including technological advances in the medical field and standards for transfusion medicine and our ability to successfully implement products that incorporate such advances and standards, product demand, market acceptance, regulatory uncertainties, the effect of economic and political conditions, the impact of competitive products and pricing, blood product reimbursement policies and practices, foreign currency exchange rates, changes in customers’ ordering patterns, the effect of industry consolidation as seen in the plasma market, the effect of communicable diseases and the effect of uncertainties in markets outside the U.S. (including Europe and Asia) in which we operate and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The foregoing list should not be construed as exhaustive. The forward-looking statements are based on estimates and assumptions made by management of the Company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results and experience could differ materially from the forward-looking statements.
CONTACT: Julie Fallon Tel. (781) 356-9517 Alternate Tel. (617) 320-2401 fallon@haemonetics.com
Haemonetics Corporation
CONTACT: Julie Fallon of Haemonetics Corporation, +1-781-356-9517, or+1-617-320-2401, fallon@haemonetics.com
Web site: http://www.haemonetics.com//
