FDA Approves Novel Pall System with Built-In Filtration Step for Safer Blood Transfusion Following Orthopedic Surgery.

Business Editors/Health/Medical Writers

EAST HILLS, N.Y.--(BUSINESS WIRE)--May 29, 2003

The Food and Drug Administration cleared for market the Pall Corporation (NYSE: PLL) DONOR(TM) Blood Reinfusion System to provide a safer autologous blood transfusion for patients undergoing orthopedic surgery.

The DONOR System allows the surgeon to easily collect a patient's own blood for reinfusion following the surgical procedure, avoiding the need for and risks associated with an allogeneic (donor blood) transfusion. It mitigates these transfusion risks with the incorporation of the Pall LipiGuard(R) VS filter media technology into the system. It is the only reinfusion system where the filtration step is an integral part of the complete package.

"The DONOR System offers advantages over other available post-operative blood collection and reinfusion systems," said Roberto Perez, President of Pall Medical. "Building the filtration step into the system precludes the time and costs needed to add filters while also ensuring a consistent filtration result from patient to patient."

In studies with orthopedic surgical patients, the LipiGuard VS filter media has been shown to significantly reduce harmful contaminants. These include leukocytes (white blood cells), lipids, activated proteins and cell and tissue debris which can be harmful when reinfused back into the patient.

Unlike other systems that require mechanical devices or pumps, the DONOR System uses a patented vacuum technology for constant gentle wound suction that is automatically regulated. This obviates the staff time needed to set the system and continuously monitor it to ensure consistent levels of pressure. Studies have shown that constant suction at consistent levels prevents increased bleeding while also promoting optimal wound closure and healing. Since DONOR is a closed system, it also reduces the risk of airborne contamination.

In a clinical study with patients undergoing total knee replacement conduced at the North Hampshire Hospital in the UK, the DONOR System was shown to be both safe and easy to use. None of the patients suffered infection.

"With growing concern about the safety of the blood supply coupled with an aging population necessitating an increase in orthopedic surgery, we anticipate that the DONOR System will increasingly become part of routine practice for an even wider variety of orthopedic procedures. It gives surgeons an easy-to-use solution to ensure their patients receive a safer blood transfusion," Mr. Perez added.

Orthopedic surgeries frequently require blood transfusion support. There were about 1.5 million orthopedic surgeries for joint (hip and knee) replacement, fracture repair and spinal fusion performed in the U.S. last year, and the number of procedures is expected to increase by 8 percent annually. In many of these procedures, surgeons drain the surgical wounds post-operatively and collect the patient's own blood.

The DONOR Pre-Evacuated Post-Operative Autologous Blood Reinfusion System is currently available in the United Kingdom, Canada and throughout the Middle East. It will be available in the U.S. this summer.

Pall Medical, part of the Company's Life Sciences business, is the worldwide leader in leukocyte reduction filtration technologies for both red blood cells and platelets. The Company is involved in extensive research and development in many areas of blood safety.

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 revenues for fiscal 2002 were about $1.3 billion. The Company is headquartered in East Hills, New York. Further information can be found on its Web site http://www.pall.com.