VIASYS Healthcare Inc. Announces U.S. Food and Drug Administration Approval To Launch 3100B High Frequency Oscillatory Ventilator.Business Editors & Health/Medical Writers PHILADELPHIA--(BW HealthWire)--Nov. 8, 2001 VIASYS Healthcare Inc. (effective 11/16/01 (NYSE NYSE See: New York Stock Exchange :VAS)), today announced that they have received approval from the U.S. Food and Drug Administration to launch their SensorMedics Model 3100B High Frequency Oscillatory Ventilator into commercial distribution in the United States for the treatment of acute respiratory failure in adults and large children. The pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. version of this ventilator has become the standard of care in the treatment of premature infants and children since its introduction in 1991. Acute Respiratory Distress Syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. (ARDS Ards District (pop., 2001: 73,244), Northern Ireland. Formerly part of County Down, Ards was established as a district in 1973. Much of its land is devoted to crops and pasture. Newtownards, settled c. 1608 by Scots, is its administrative seat and manufacturing centre. ), the most severe form of acute respiratory failure, is estimated to affect more than 100,000 people in the United States annually and result in death in 40 to 60 percent of the cases. The 3100B uses higher distending pressures than conventional ventilators to open the diseased lung units and improve the delivery of oxygen. It then uses very rapid (typically from 180 to 420 breaths per minute), but extremely small breaths to remove carbon dioxide, thereby reducing injury to the lungs. The 3100B is a Class III (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) medical device that required a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. controlled clinical trial controlled clinical trial, n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo. to demonstrate safety and efficacy in treating adults and large children with ARDS. High frequency ventilators are the only ventilators classified as Class III by 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. . The clinical trial developed and run by SensorMedics was performed at 10 university affiliated medical centers in the United States and Canada and included 148 patients treated by either the 3100B or a conventional ventilator. The group of patients treated with the 3100B had a 29% relative decrease in mortality as compared with the conventionally ventilated patients (52% to 37%). Although this difference was not statistically significant, an analysis of a subset of 80 patients identified with better lung function at entry demonstrated a larger and more significant reduction in mortality from 52% to 26% at 30 days (p = 0.018) that was sustained at 6-months (p = 0.045). The data from the three year trial was presented to an FDA Advisory Panel that recommended the 3100B for approval. "I am very pleased that we will now be able to extend the benefits of high frequency oscillatory ventilation, that we have previously demonstrated in neonates and pediatrics, to the adult population," announced Alex Stenzler, vice president of Advanced Technologies for VIASYS Healthcare's Respiratory Technologies Group. He added: "With the annual incidence of ARDS at more than 100,000, we anticipate that use of the 3100B in adult ARDS may save several thousand lives, or the population of a small town, in the United States every year." VIASYS Healthcare is a global, research-based medical technology company focused in respiratory technology, neuro-care and medical/surgical products. VIASYS' products are marketed under well-recognized brand names such as SensorMedics, Bird, Bear, Nicolet, and Jaeger. VIASYS has headquarters in Conshohocken, Pa. and effective Nov. 16, 2001 will be listed on the New York Stock Exchange New York Stock Exchange (NYSE) World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. under the symbol VAS. For further information contact the SensorMedics marketing department in the United States: 800/520-4368; in the Netherlands: SensorMedics BV (31) 30-289711. |
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