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Lung valve offers hope Topeka doctor says patient was 'struggling to

Topeka Capital-Journal, The, Jan 6, 2005 by Michael Hooper Capital-Journal

Please see VALVE, Page 7A

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Valve: Emphysema afflicts millions

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This is a photo of the Emphasys Zephyr Endobronchial Valve, which is about the size of a pencil eraser.

By Michael Hooper

THE CAPITAL-JOURNAL

A Topeka doctor is part of an international study that may have significant implications for the treatment of people suffering from emphysema.

Dr. William Leeds implanted two special valves into the lung of a patient suffering from emphysema on Wednesday at Stormont-Vail Regional Health Center.

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Leeds is the first doctor in the country to implant the latest version of the valve, developed by Emphasys Medical Inc., of Redwood City, Calif. The latest valve was first used in Europe.

The valve, which is the size of a pencil eraser, is designed to isolate diseased portions of the lung to stimulate and improve breathing in other areas of the lung, Leeds said. The valve is considered an alternative to lung reduction surgery, which is risky and expensive, Leeds said.

The patient who received the valve Wednesday was in the advanced stages of chronic obstructive pulmonary disease.

"He is struggling to stay alive for his grandchildren and his wife," Leeds said. His life "is severely impaired by exercise limitations, hospitalizations and tremendous amounts of medication."

Wednesday's procedure took about a half-hour to install two valves in the upper right lobe through a bronchoscope, said Mike Welch, Emphasys clinical development manager.

In 2003, the FDA approved the valve for a trial study in the United States. Emphasys has developed 30 sites in the United States and 20 in Europe for trial purposes. The study will enroll 270 participants. Two groups of patients will both receive optimal medical management and one group will receive the miniature valve. The study will measure quality of life and assess cost effectiveness.

Todd Cornell, area director for Emphasys Medical Inc., said the first data from the VENT study showed significant improvement in patients who were measured by a six-minute walk test and FEV 1 test, which measures how much air a patient can blow out in one second.

Leeds is an owner in Topeka Pulmonary & Sleep Medicine and is the medical director of Veritas Clinical Specialties, which performs research and clinical trials with pharmaceutical firms and medical device manufacturers. He and his wife, Luanne, spent about $2 million to renovate the building at 515 S.W. Horne.

Leeds' first patient in the study received four valves on Dec. 8 at Stormont-Vail Regional Health Center.

"This was a professional woman who has very advanced levels of emphysema," he said. "Initially, when I saw her, she was fully disabled. Using good clinical practices, she was able to return to work part time.

"After the procedure on Dec. 8, she went from having conversational shortness of breath to immediately losing that shortness of breath," he said. "Also, her oxygen requirement dropped significantly."

"She has a family member who is a competitive volleyball player. She had never been able to get to a volleyball game because of a shortness of breath. The night of discharge, she went to a volleyball game," he said.

The patient is now working full time.

"Is that placebo? I don't think so. But who knows. It's a controlled trial," Leeds said.

Great cooperation in the medical community created the opportunity for the procedure being done at Stormont-Vail, Leeds said.

Wednesday's operation was paid for by Emphasys Medical Inc., which received $20 million as a startup venture capital company. It recently received another $27 million in venture capital, Welch said.

Emphasys is funded by The Foundry, a venture capital firm that has funded startup medical devise companies.

The VENT study will include about 270 patients, Welch said. Patients will receive follow-up monitoring for at least a year. Results of the study will be used to seek FDA approval to launch the product in the United States.

Leeds said the valve would be a significant tool that doctors can use to improve the lives of patients suffering from chronic obstructive pulmonary disease. There aren't many options for treatment, he said.

"This is the first time that we have had anything that will dramatically change the way we treat COPD," he said.

Millions of Americans suffer from emphysema, primarily caused by smoking, leading to the irreversible breakdown of lung tissue. As the disease advances, the most damaged areas of the lung overinflate within the chest cavity, trapping air and preventing the healthier lung areas from functioning.

Leeds came to Topeka from Camden, N.J.

Lung valve offers hope Topeka doctor says patient was 'struggling to

Topeka Capital-Journal, The, Jan 6, 2005 by Michael Hooper Capital-Journal

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