Bard Concludes Enrollment in Infection Control Endotracheal Tube Trial.MURRAY HILL, N.J. -- C. R. Bard C. R. Bard, Inc. (NYSE: BCR) is one of the large S&P 500 companies of the United States, a surgical specialties and hospital medical device manufacturer in Murray Hill, New Jersey. It is named after its founder, who sold the company within only a few years of its founding. , Inc. (NYSE NYSE See: New York Stock Exchange :BCR BCR B Cell Receptor BCR Business Communications Review (magazine) BCR Banca Comerciala Romana (Romanian bank) BCR Breakpoint Cluster Region BCR Benefit/Cost Ratio BCR Bay City Rollers ) today announced that it has concluded enrollment in its respiratory infection control (RIC) endotracheal endotracheal /en·do·tra·che·al/ (en?do-tra´ke-al) within or through the trachea. en·do·tra·che·al adj. Within or passing through the trachea. (ET) tube clinical trial. Based on Data Safety Monitoring Board review and input, the company believes that current trends in the data support the trial's secondary endpoint, the delayed onset of ventilator associated pneumonia (VAP). As a result, the company has decided to conclude enrollment in the study and to pursue 510(k) concurrence from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) after trial follow-up is completed. The trial is a prospective, multi-center, 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. , sequential design clinical study of the incidence and time to onset of VAP in patients who require mechanical ventilation. VAP is one of the most costly hospital acquired infections and has an associated mortality rate greater than 50 percent. It is especially prevalent in hospital intensive care units where patients are typically on an endotracheal tube for one to 10 days. The company's endotracheal tube incorporates its proprietary, silver-eluting technology. Subject to FDA concurrence, the company continues to anticipate launch of the product in the first half of 2007. C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, N.J., is a leading multinational developer, manufacturer, and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products. This press release may contain forward-looking statements within the meaning of 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, which are based on management's current expectations, the accuracy of which is necessarily subject to risks and uncertainties. These statements are not historical in nature and use words such as "anticipate", "estimate", "expect", "project", "intend", "forecast", "plan", "believe", and other words of similar meaning in connection with any discussion of future operating or financial performance. Many factors may cause actual results to differ materially from anticipated results including product developments, sales efforts, income tax matters, the outcomes of contingencies such as legal proceedings, and other economic, business, competitive and regulatory factors. The company undertakes no obligation to update its forward-looking statements. Please refer to our December 31, 2005 10-K for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion