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Plc Systems, | AMEX:PLC | AMEX | Ordinary Share |
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BW20030501002139 20030502T060010Z UTC ( BW)(PALL-CORPORATION)(PLC) Product Launch Business Editors UK REGULATORY NEWS EAST HILLS, N.Y--(BUSINESS WIRE)--May 2, 2003-- Pall Receives FDA Nod to Market Novel Blood Filtration System Pall Corporation (NYSE:PLL) announced today that the Food and Drug Administration (FDA) granted clearance to market its new Leukotrap WB(R) Filtration System. This incorporates Pall's patented SAVE technology, an automated blood recovery and air removal system that enables maximum recovery of red blood cells and plasma. It is the first whole blood collection, filtration and pre-storage system that eliminates the need for "burping," the repetitive manual manipulation required to express air from filtered whole blood. SAVE stands for Sterile Air Venting Elimination. After whole blood is collected, air is traditionally forced out of the blood bag by burping -- manually squeezing-- the bag before the blood undergoes additional processing prior to transfusion. Technicians can squeeze as many as 60 bags per hour, one bag every minute. This is a tedious and time-consuming task that has been associated with repetitive strain injuries. The SAVE system automatically and reliably removes the air, eliminating this manipulation step. The presence of air can impede subsequent component processing and potentially interfere with visual inspection. "We anticipate rapid adoption of this new system because it is easy to use, overcomes the problems associated with burping and provides the assurance of maximum blood recovery without compromising filter performance," said Roberto Perez, President of Pall Medical. "It also provides rapid filtration times and consistently low levels of residual leukocytes (white blood cells) in processed red cells and plasma, giving customers the consistency and reliability they expect from our filters." The new system is also configured with the Pall Sample Diversion Pouch, recently cleared for market by the FDA to divert the initial volume of donor blood during collection, as part of a bacterial risk management program. High levels of bacteria that can contaminate a blood transfusion are generally found in the first blood drawn from the venipuncture skin site of a blood donation. "This unique combination of technologies provides blood centers a user friendly way to enhance transfusion safety and efficiency," Mr. Perez added. "This is one more addition to the Pall product line of next generation leukoreduction systems to help ensure that transfused blood is as safe as possible for all who need this life saving resource." These new technologies are the latest in a spate of recent FDA clearance to market for several new transfusion products from the Company. These include the Pall BDS (bacterial detection system), which tests platelets for the presence of bacteria, and the RC2D Leukocyte Reduction Filter, which maximizes plasma recovery and improves blood processing efficiency even under extreme processing conditions. The Leukotrap WB Filtration System with SAVE will be available to blood centers within a few weeks. About Pall Corporation Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, municipal drinking water and aerospace. Total revenue for Pall Corporation is $1.3 billion. The Company is headquartered in East Hills, New York, and has operations in more than 30 countries. Further information can be found on its web site at http://www.pall.com. Short Name: Pall Corporation Category Code: PRL Sequence Number: 00004473 Time of Receipt (offset from UTC): 20030501T190940+0100 --30--BW/ny* DB/ny CONTACT: Pall Corporation Media Inquiries: Roberto Perez, 516/801-9555 Roberto_Perez@pall.com or Investor Relations Inquiries: Diane Foster, 516/801-9848 Diane_Foster@pall.com KEYWORD: NEW YORK UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL DEVICES MEDICAL GOVERNMENT PRODUCT SOURCE: Pall Corporation Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com
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