Date:	September 26, 2007
Contact:	Karen Senger , OSU Center for Health Sciences (918) 561-1219

OSU Center for Respiratory Medicine implants valves in first three patients in U.S. pivotal trial of treatment for severe emphysema
                                                 
TULSA, OK – The Center for Respiratory Medicine at Oklahoma State University Center for Health Sciences is participating as a clinical trial site evaluating an implanted device for the treatment of severe emphysema, the IBV® Valve System, and implanted the device on Sept. 19 in the first three patients to participate in the national trial.      

Safety and effectiveness data from the IBV® Valve Trial will be submitted to the U.S. Food and Drug Administration (FDA) for approval to market the device in the United States. The IBV® Valve System was developed and is manufactured by Spiration Inc., of Redmond, Wash.

“We are excited about this opportunity for eligible emphysema patients in northeastern Oklahoma to experience this revolutionary new device that could ultimately ease their suffering,” said Daniel Nader, D.O., director of the OSU Center for Respiratory Medicine and clinical assistant professor of internal medicine.

More than three million Americans are living with emphysema, a condition that is chronic and severely impacts quality of life.  People with severe emphysema struggle with each breath and therefore cannot do very simple things, like simultaneously walking and talking, that most people take for granted.  Many do not respond well to current medical treatments or are not eligible for major surgery such as lung volume reduction or lung transplantation.  The IBV® Valve System, which is much less invasive than surgery, may one day offer a new treatment option to improve the quality of life for these patients.   

The OSU Center for Respiratory Medicine is actively recruiting patients for the trial. The study is open to men and women age 40 to 74 who have been diagnosed with predominantly upper lobe emphysema and severe dyspnea (shortness of breath).  Eligible patients must also be able to participate in pulmonary function and standardized exercise tests, have not smoked for four months and are willing to not smoke during the trial.  Volunteers must be willing to be assigned randomly to one of two groups: One group will receive the IBV® Valve System while the other group will serve as a control group and will not receive the IBV® Valve System.  Additional criteria must be met for participation in the study.  For information about the trial and to see if a patient is qualified to participate call the toll-free number (877) 547-8839 or visit www.emphysematrial.com.

About the IBV® Valve Trial
The IBV® Valve Trial is a randomized, prospective, double-blind clinical trial that will enroll up to 500 patients at up to 40 sites in the United States.  The objective of the study is to demonstrate the safety and effectiveness of the IBV® Valve treatment.  The primary endpoints of the study will be measured at six months.  Patients enrolled in the control arm of the study will be eligible to receive treatment with the IBV® Valve System after completion of the six-month study.

About the IBV® Valve System
For the treatment of severe emphysema, the IBV® Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas. During the procedure, a catheter is passed through a bronchoscope, a flexible tube passed into the bronchial tubes through the mouth, to deploy the small umbrella-shaped valves into the airways of the most diseased upper lobes of the lungs.  Although the valves are intended to be permanent, they may be removed if necessary.

About Emphysema
Emphysema, a component of Chronic Obstructive Pulmonary Disease (COPD), is a common, debilitating lung disease with no cure in which the tiny air sacs that make up the lungs (alveoli) are enlarged or destroyed.  This impairs the exchange of oxygen and carbon dioxide with the blood, reduces the lungs’ ability to exhale air, and is accompanied by coughing and breathing difficulties, initially with exertion and eventually also while at rest.  The most common cause of emphysema is an inflammatory reaction to inhaled smoke.  Currently available treatments for emphysema are generally palliative and include medications, home oxygen therapy, pulmonary rehabilitation, lung volume reduction surgery and lung transplantation.

About OSU Center for Health Sciences
Oklahoma State University Center for Health Sciences in Tulsa, Okla., offers programs in osteopathic medicine, biomedical sciences and forensic sciences, with an emphasis on preparing physicians for rural and under-served Oklahoma. The OSU College of Osteopathic Medicine has been nationally ranked by U.S. News & World Report as one of the top medical schools in the nation for the past seven years. OSU operates six clinics, five in Tulsa and one in Enid.