Bard Concludes Enrollment in Infection Control Endotracheal Tube Trial

MURRAY HILL, N.J. -- C. R. Bard, Inc. announced that it has concluded enrollment in its respiratory infection control (RIC) endotracheal (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 (FDA) after trial follow-up is completed.

The trial is a prospective, multi-center, randomized, 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. is a multinational developer, manufacturer, and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.

Source: Business Wire

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