BRAINTREE, Mass., Oct. 27 /PRNewswire-FirstCall/ -- Haemonetics Corporation announced today that the Company's SmartSuction HARMONY surgical suction pump has received 510(k) marketing clearance by the U.S. Food and Drug Administration. The SmartSuction HARMONY system provides high air flow, self-regulating suction that optimizes removal of fluid from the surgical field at low suction levels. The HARMONY system is designed to supply suction for the Haemonetics OrthoPAT(R), cardioPAT(R) and Cell Saver(R) autotransfusion systems.
In surgical blood salvage, also known as "autotransfusion," blood lost by a patient is collected during or after the surgery, cleaned, and made available for transfusion back to the patient. This process ensures that a patient is transfused with the safest blood possible, his own. Autotransfusion devices use suction, usually provided by manually regulated wall suction systems, to collect the blood and fluid from the surgical field. The SmartSuction HARMONY system, a free standing device which completely replaces wall suction, will enhance surgeons' ability to clear fluids from the surgical field and collect the patient's red cells for reinfusion.
In surgery, the need for good visibility and fast clearance of the surgical field often conflicts with the need for gentle red blood cell recovery. Because of its unique ability to combine high suction rates with the low vacuum pressures recommended for optimal blood cell recovery, the SmartSuction HARMONY surgical suction pump is the only device to meet both needs, providing suction that is both gentle and strong. The SmartSuction HARMONY is easy to use, and eliminates the need to adjust suction levels during surgery.
"We believe this exciting technology will make a significant contribution to surgical practice making it easier for surgeons to simultaneously visualize the field, and effectively salvage red blood cells for reinfusion," said Brian Concannon, President of Haemonetics' Patient Division. "The SmartSuction HARMONY system enhances our autotransfusion value proposition and represents our first foray beyond autotransfusion and into surgical patient management."
The HARMONY device was developed as one of the first in a family of products that will be based on the SmartSuction(R) technology that Haemonetics acquired from Harvest Technologies Corporation in August of 2004. (See related press release dated August 30, 2004). Haemonetics is continuing development work on the other products in this family.
For more information on the SmartSuction HARMONY, visit Haemonetics' website at http://www.haemonetics.com/site/content/km/factSheet.asp.
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 CorporationCONTACT: Julie Fallon of Haemonetics Corporation, +1-781-356-9517, or+1-617-320-2401, fallon@haemonetics.com
Web site: http://www.haemonetics.com//
