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Spiration, Inc. Announces First Patient Enrollment in U.S.
Pivotal Trial of Minimally Invasive Treatment for Severe
Emphysema
IBV® Valve System May Improve Quality of Life for Patients
Living with Debilitating Condition
Redmond, Wash. – Sept. 26, 2007 – Spiration, Inc., a developer
of novel medical technology designed to benefit patients with
acute and chronic conditions of the lung, today announced that
the first patients have been enrolled in the company’s IBV Valve
Trial in the United States. The purpose of the trial is to
generate safety and effectiveness data for submission to the
U.S. Food and Drug Administration (FDA) for approval to market
the company’s IBV Valve System in the United States for the
treatment of patients with severe emphysema.
“More than three million Americans are living with emphysema, a
condition that is chronic and severely impacts quality of life,”
said Rick Shea, president and CEO, Spiration®. “We are excited
about the milestone that the initiation of this pivotal trial
represents for Spiration and for patients with severe emphysema,
many of whom do not respond well to current medical treatments
or are not eligible for major surgery such as lung volume
reduction or lung transplantation.”
The first patients were enrolled in the pivotal trial by Daniel
Nader, DO, FCCP, clinical assistant professor of internal
medicine and director of the Oklahoma State University Center
for Respiratory Medicine in Tulsa, Oklahoma.
“There are currently few treatment options for people with
severe emphysema, who struggle with each breath and therefore
cannot do very simple things that most people take for granted,
such as simultaneously walking and talking,” said Dr.Nader.
“Spiration’s valve therapy – which is much less invasive than
lung surgery – may one day offer a new treatment option to
improve quality of life for these patients.”
The IBV Valve Trial is a prospective, randomized, blinded
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 period.
For the treatment of emphysema, the IBV Valve System is designed
to redirect airflow from diseased portions of the lung to
healthier areas. During the minimally invasive procedure, a
catheter is passed through a bronchoscope (a flexible tube
passed into the bronchial tubes through the mouth or nose) to
deploy the small umbrella-shaped valves into the airways of the
upper lobes of the lungs. Although the valves are intended to be
permanent, they are designed to be removed via a minimally
invasive procedure if necessary.
The IBV Valve Trial design is based on results of a pilot study.
“Findings of the pilot study are encouraging, and suggest that
the IBV Valve may provide improvements in quality of life for
many patients. We hope to confirm these results in the pivotal
trial,” said Daniel Sterman, M.D., director of Interventional
Pulmonology of the University of Pennsylvania Medical Center in
Philadelphia, who presented further results from the pilot study
last week at the European Respiratory Society’s Annual Congress
in Stockholm, Sweden.
Study investigators are actively recruiting patients for the IBV
Valve Trial. The study is open to men and women age 40 to 74 who
have been diagnosed with predominantly upper lobe emphysema and
shortness of breath with exertion. Eligible patients are 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. Additional criteria must be met for
participation in the study. For more information, including
trial site locations, please visit
www.emphysematrial.com or call (877) 547-8839.
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 Spiration’s IBV Valve System
Spiration’s IBV Valve System is a minimally invasive device
under investigation in the U.S. for the treatment of severe
emphysema. The system has received CE Mark approval for the
treatment of diseased and damaged lung in Europe and is an
investigational device in Canada.
About Spiration Inc.
Spiration Inc. is committed to improving quality of life for
patients with acute and chronic conditions of the lung through
the development of novel therapies. Founded in 1999 in Redmond,
Wash., the privately held company is backed by prominent
investors including Three Arch Partners, New Enterprise
Associates, Versant Ventures, New Leaf Ventures, InterWest
Partners, Investor Growth Capital, GE Capital, Boston Scientific
Corporation and Olympus Medical Systems Corporation. For more
information, visit the company’s website at
www.spiration.com.
CAUTION – Investigational Device. Limited by Federal (or United
States) Law to Investigational Use.
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