FDA Clears Pall's LaparoShield System For Minimally Invasive Abdominal Surgery; New System Reduces Risk of Complications and Speeds Recovery.Business Editors/Health/Medical Writers EAST HILLS, N.Y.--(BUSINESS WIRE)--March 11, 2004 Pall Corporation (NYSE NYSE See: New York Stock Exchange : PLL PLL - phase-locked loop ) today announced Food and Drug Administration clearance to market its new LaparoShield(TM) Conditioned Insufflation insufflation /in·suf·fla·tion/ (-sah-fla´shun) 1. the act of blowing a powder, vapor, or gas into a body cavity. 2. finely powdered or liquid drugs carried into the respiratory passages by such devices as aerosols. Gas (CIG CIG Ceiling (height above ground level to base of clouds) CIG Conference Intergouvernementale (French: Intergovermental Conference) CIG Conservation Innovation Grants (USDA NRCS) ) System. By conditioning the carbon dioxide carbon dioxide, chemical compound, CO2, a colorless, odorless, tasteless gas that is about one and one-half times as dense as air under ordinary conditions of temperature and pressure. (CO2) gas used in laparoscopic surgeries, it becomes more characteristic of the environment of the abdominal cavity. Heated and humidified carbon dioxide has been shown to reduce recovery times, post-operative pain and complications. This provides a new level of safety and comfort for the rapidly growing number of patients undergoing minimally invasive abdominal surgery. The LaparoShield CIG System provides warm and humidified CO2 into a patient's abdominal cavity for insufflation during laparoscopic surgery. Insufflation is the standard medical practice where gas is blown into a body cavity in order to create space for surgical procedures. Before any gas is introduced into a patient's body, the LaparoShield CIG System conditions it to greater than 95 percent relative humidity and a temperature of approximately 100 degrees Fahrenheit. These conditions have been shown to reduce negative impact on patients, such as tissue damage and hypothermia hypothermia Abnormally low body temperature, with slowing of physiological activity. It is artificially induced (usually with ice baths) for certain surgical procedures and cancer treatments. (lowered core body temperature). "Pall's LaparoShield CIG System establishes physiologically normal conditions for carbon dioxide gas entering a patient and, just as importantly, maintains those conditions throughout surgery," said Roberto Perez, President, Pall Medical. "It alleviates problems of post-operative pain and slowed recovery time that can be caused by insufflation with gas that doesn't consistently mirror the environment in the human body." When unconditioned unconditioned /un·con·di·tion·ed/ (un?kon-dish´und) not a result of conditioning; unlearned; occurring naturally or spontaneously. or inconsistently conditioned CO2 is used, the low temperature and dryness of the gas can severely dry tissue, resulting in cellular death, and also lower the patient's body temperature. This can increase the occurrence and intensity of post-operative pain and nausea, recovery time and the possibility of adhesions in the abdominal cavity, which can cause later complications. Surgeons using non-conditioned gas also experience fogging of the laparoscope laparoscope /lap·a·ro·scope/ (lap´ah-rah-skop?) an endoscope for examining the peritoneal cavity. lap·a·ro·scope n. lenses, which can slow and complicate their ability to perform the operation. "We're pleased that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has cleared the LaparoShield CIG System so expeditiously since it provides hospitals with a highly efficient way to make abdominal surgeries safer and easier for both patients and their doctors," Mr. Perez added. The LaparoShield CIG System offers several additional features that contribute to its efficiency and practicality. A high-visibility temperature indicator is conveniently located for easy monitoring during surgery. A single syringe of sterile water injected into the system prior to surgery humidifies over 350 liters of CO2, maintaining consistent performance for as long as two to three hours to accommodate longer surgeries. This avoids distracting medical staff from the surgical procedure to replenish the system. It also includes a low resistance filter with a bacterial/viral removal efficiency of greater than 99.999 percent, significantly reducing bacterial and viral threats. The filter also prevents backflow backflow /back·flow/ (-flo) reflux or regurgitation (1). pyelovenous backflow drainage from the renal pelvis into the venous system occurring under certain conditions of back pressure. of bodily fluids avoiding delays during surgery and contamination of equipment. Even with its advanced filtration, the LaparoShield CIG System is optimized to ensure an unrestricted and consistent flow of CO2 from source to patient. Minimally invasive abdominal surgeries are becoming increasingly popular due to their safety profile and shortened recovery times and are increasing at a rate of 14 to 16 percent per year. Most notably, bariatric surgeries, which include stomach banding and gastric bypass, are also experiencing rapid growth. According to the American Society for Bariatric Surgery The American Society for Bariatric Surgery (ASBS) is a United States medical organization founded in 1983 with the mission of advancing bariatic surgery. External links
Pall's new LaparoShield CIG System complements the Company's LaparoShield(TM) Laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies Smoke Filtration (LSF LSF Lisofylline, see there ) System, which filters gas contaminated with smoke, bioaerosols and biomaterials exiting insufflated abdominal cavities during surgery. These airborne hazards pose a serious health risk to everyone present in the operating room. By adopting these systems, the safety and efficacy of laparoscopic surgery for both medical staff and patients is increased significantly. The LaparoShield CIG System will be available in April 2004. About Pall Corporation Pall Corporation is the leader in the rapidly growing fields 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, aerospace and broad industrial markets. Total revenues are $1.6 billion. The Company headquarters are in East Hills, New York East Hills is a village in Nassau County, New York on the North Shore of Long Island. It is considered part of the Greater Roslyn area, which is anchored by the Village of Roslyn. As of the United States 2000 Census, the village population was 6,842. with operations in more than 30 countries. Further information is available at www.pall.com. This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements are based on current Company expectations and are subject to risk and uncertainties which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at www.pall.com and is included in the Company's reports filed with the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at www.sec.gov. |
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