Emphasys Medical Initiates Pivotal Trial For New Emphysema Therapy

Published: May 26, 2004

REDWOOD CITY, Calif., May 26 /PRNewswire/ -- Emphasys Medical Inc., a medical device company focused on improving the lives of patients with emphysema, today announced the initiation of the Endobronchial Valve for Emphysema Palliation Trial (VENT) to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV). The EBV is a miniature valve that is implanted in the patient's airways to isolate the diseased portion of the lung and restore airflow to the healthier portions. Emphasys is the first company to enter into a pivotal trial investigating a minimally-invasive treatment for emphysema.

The multi-center, randomized study will enroll 270 participants across the United States and Europe. The study will have two arms: the control arm will receive standard optimal medical management and the treatment arm will receive the Emphasys EBV procedure. Patients in both arms will undergo pulmonary rehabilitation prior to randomization. The study's primary efficacy endpoints are improvement in lung function and exercise tolerance. The study will also measure improvement in quality of life and assess cost effectiveness.

"There are currently very few treatment options for people with advanced emphysema. Previous studies have shown that lung volume reduction surgery offers relief in select patients by surgically removing the diseased portion of the lung," said Armin Ernst, M.D., director of the Center for Interventional Pulmonology at Boston's Beth Israel Deaconess Medical Center and an investigator for the VENT study. "Although lung volume reduction surgery can improve overall lung function, it is highly invasive and involves significant risk. For some patients, these risks outweigh the potential quality of life improvement."

"The goal of the VENT study is to test a new, bronchoscopic approach to lung volume reduction by implanting one-way valves in the most diseased portion of the lungs," added Frank Sciurba, M.D., associate professor of medicine at the University of Pittsburgh School of Medicine and the principal investigator for the VENT study. "This procedure is minimally-invasive and may involve fewer risks and reduced recovery time compared to surgical alternatives."

The Emphasys EBV, which is about the size of a pencil eraser, is designed to be removable once implanted. This allows the procedure to be potentially reversible if clinically warranted. The procedure is performed under routine anesthesia and utilizes standard catheter delivery techniques.

"The healthcare and societal costs of managing patients with advanced emphysema are significant and current treatment options are limited," said John McCutcheon, president and chief executive officer of Emphasys Medical. "We now have clinical experience involving over 140 patients treated in international clinical studies. In the VENT study, we expect to validate the improvements in pulmonary function, exercise tolerance, and quality of life that were observed in these initial trials."

About Emphysema

Emphysema is a debilitating disease that afflicts more than three million Americans. The disease is caused primarily by smoking and leads to a progressive, irreversible breakdown of lung tissue. This breakdown reduces the amount of lung tissue available for gas exchange and also impairs the lung's ability to inflate and deflate normally. As the disease advances, the most damaged areas of the lung over inflate within the chest cavity, trapping air and preventing the healthier lung areas from functioning normally. Eventually breathing becomes more difficult, leaving patients constantly feeling out-of-breath.

About Emphasys Medical

Emphasys Medical is focused on improving the lives of patients with emphysema and other pulmonary diseases through the development of minimally-invasive devices that help patients breathe easier. Headquartered in Redwood City, CA, privately held Emphasys works with leading pulmonologists and surgeons around the world and has an experienced management team in place to manage the company through to commercialization.

For further information, please contact: Media, Carin Canale, ccanale@irpr.com, or Michael Moore, mmoore@irpr.com, both for Emphasys Medical Inc., +1-858-527-3497; or Clinical Trials, MediciGroup, Inc., +1-866-303-5080.

Emphasys Medical

CONTACT: Media, Carin Canale, ccanale@irpr.com, or Michael Moore,mmoore@irpr.com, both for Emphasys Medical Inc., +1-858-527-3497; or ClinicalTrials, MediciGroup, Inc., +1-866-303-5080

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