Healthcare Industry News:  IBV Valve System 

Devices

 News Release - October 8, 2008

Spiration, Inc. Announces European Launch of Minimally Invasive Pulmonary Device

Air Leak Compassionate Use Case Studies Presented at Annual European Respiratory Society Congress

REDMOND, Wash. & BERLIN--(HSMN NewsFeed)--Spiration, Inc., a developer of novel medical devices designed to benefit patients with acute and chronic conditions of the lung, today announced that Olympus has initiated the European launch of the company’s IBV® Valve System.

The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung. In Europe, the system has received market clearance through CE Mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks, a complication that can occur following lung surgery or as a consequence of certain serious lung diseases.

Olympus is launching the IBV Valve initially to select European physicians and will broaden distribution to additional accounts in the coming months.

“I am excited that this new treatment option is now available in Europe, where there is a significant unmet need for minimally invasive approaches to improving quality of life for people with emphysema,” said Vincent Ninane, M.D., of the St. Pierre Hospital in Brussels, Belgium, who presented information about the European study of the IBV Valve at this week’s European Respiratory Society (ERS) Annual Congress in Berlin. "Spiration's device holds promise for patients with this debilitating condition, many of whom do not respond well to current medical treatments or are not eligible for or elect not to undergo major surgery such as lung volume reduction or lung transplantation."

Earlier this year Spiration® announced that it had granted Olympus and its distributors exclusive marketing and distribution rights for the company’s IBV Valve System in 43 European countries including the United Kingdom and countries belonging to the European Union, representing the broadest distribution arrangement for a bronchoscopic treatment for emphysema in Europe to date. Spiration will manufacture the product.

“The European availability of the IBV Valve System is an exciting milestone for Spiration. We are pleased by the positive reception from physicians at ERS and we look forward to working with Olympus to bring this important therapy to patients in Europe,” said Rick Shea, president and CEO, Spiration, Inc.

Case Studies of IBV Valve System for Air Leaks Presented at ERS

Daniel Sterman, M.D., director of Interventional Pulmonology at the University of Pennsylvania Medical Center in Philadelphia, presented an evaluation of the compassionate use of the IBV Valve System for the treatment of air leaks in six patients during this week’s ERS Annual Congress.

Air leaks are a common complication of surgery caused by lung tissue that has not completely closed and sealed, resulting in an accumulation of air in the chest that can cause breathing difficulties. They can also result from serious diseases of the lung and contribute to significant morbidity and mortality.

“In these very complex compassionate use cases, the IBV Valve System was safe and effective for the treatment of air leaks,” said Dr. Sterman. “I believe this is a very promising clinical application for this device.”

The U.S. Food and Drug Administration’s (FDA) compassionate use provision allows access for patients who do not meet the requirements for inclusion in clinical investigation but for whom the physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition.

About the IBV Valve System

The IBV Valve System is a minimally invasive treatment that has diverse applications in both acute and chronic conditions of the lung. 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 lungs. The valves are designed to be easily removed via a similar bronchoscopic procedure.

The IBV Valve System is currently under investigation in the U.S. as a new treatment option for the many people with severe emphysema who do not respond well to current medical therapies or are not eligible for or elect not to undergo invasive surgery such as lung volume reduction or lung transplantation. The device will be marketed and distributed by Olympus in Europe, where the system has received market clearance through the CE Mark for the treatment of diseased and damaged lung, an indication that includes the treatment of emphysema and the resolution of air leaks. Olympus also has development and distribution rights for the IBV Valve System in Japan.

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, Sprout Group (New Leaf Ventures), InterWest Partners, Investor Growth Capital, Saints Capital and Olympus Medical Systems Corp. For more information, visit the company’s website at www.spiration.com.


Source: Spiration

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