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INDIANA UNIVERSITY SCHOOL OF MEDICINE

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July 7, 2005

Device May Give Some Emphysema Patients Breathing Room

INDIANAPOLIS — A tiny umbrella-shaped valve designed to improve pulmonary function for emphysema patients is under investigation by researchers at the Indiana University School of Medicine.

The study, which is being conducted at Indiana University Hospital and eventually at up to 14 sites around the country, is evaluating the safety and effectiveness of the Intra-Bronchial Valve, a device developed by Spiration Inc.

The minimally invasive procedure may be an option for emphysema patients who are not candidates for lung volume reduction surgery, which removes diseased areas of the lung.

The specialized valves, which range in size from 5-to-9 millimeters, are implanted near the area of the lung damaged by emphysema using a catheter inserted through a bronchoscope. When in place, the valves contract and expand, limiting ventilation to the diseased area and allowing the healthier portion of the lung to function more efficiently.

“Initial results are promising,” says Praveen N. Mathur, M.B.B.S., professor of medicine, who is leading the IU clinical trial. “Ideally, patients experience improved lung function, exercise capability and quality of life.”

Patients, who are sedated during the procedure, usually are discharged from IU Hospital within 24 hours. Typically, they experience increased activity within three months of the procedure, Dr. Mathur says.

Three patients have undergone the IBV procedure at IU since the study got under way at the beginning of the year. IU researchers want to enroll more patients as the trial progresses, says Dr. Mathur.

Patients enrolling in the trial must:

For more information or to enroll in the study, contact Sandy Guingrich at 317-278- 3166.

Emphysema is a progressive disease affecting 3 million Americans. It causes irreversible lung damage, and, over time, the elasticity of lung tissue is lost, causing air to be trapped in air sacs and impairing the exchange of oxygen and carbon dioxide. Smoking is the major cause of the disease.

At present, the only treatments to prevent further damage wrought by emphysema are pharmacotherapy, oxygen therapy and lung transplantation or lung volume reduction surgery.

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