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Braintree, MA, Jan. 6, 2005 – Haemonetics Corporation announced today that its 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 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.
Surgeons have deployed blood salvage devices in higher blood loss surgeries, including cardiovascular surgery, over the past thirty years. 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.
Haemonetics estimates that approximately 20% 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 U.S. 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. The system complements our extensive autotransfusion product portfolio and adds to the value proposition we provide customers."
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 in the U.K. led the first customer acceptance trials. He 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. I believe the system is more convenient than the present post-operative management of blood loss."
Dr. Owens continued, "Patients in my hospital community are already requesting that the CardioPAT system be used in their surgeries. The system gives patients the advantage of getting their own blood back, but also helps ensure that banked blood is available for other patients."
Haemonetics Corporation
Haemonetics (NYSE: HAE) 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.
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Contact: Julie Fallon
Tel: (781) 356-9517
Alt. Tel: (617) 320-2401
fallon@haemonetics.com
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