Trials Begin for Lung Surgery Device

Originally Published MDDI August 2002

R&D DIGEST

Lung cancer is recognized as the leading cause of cancer deaths in the United States, with an estimated 157,000 fatalities in 2001. Another 110,000 people die each year from chronic obstructive pulmonary disease (COPD). Research efforts continue to focus on improving the available treatments for these lung conditions.

Spiration Inc. (Seattle), which is developing medical devices for the treatment of lung disease, recently began human clinical trials of its VALR surgical system. The VALR system is designed to minimize air leaks and bleeding, which are common complications associated with lung surgery.

An acute feasibility study is being conducted at the Veterans Administration Puget Sound Health Care System under the direction of principal investigator Eric Vallières, MD, associate professor of surgery at the University of Washington (Seattle). The first two procedures were performed on lung cancer patients undergoing a lobectomy.

The VALR surgical system includes a flexible elastomer sleeve loaded into a button-activated introducer where lung tissue is vacuumed into the sleeve and deployed onto the lung. Designed to apply radial compression to the lung tissue, the sleeve seals the resection site, preventing air leaks and bleeding. Sutures are threaded through the sleeve to ensure attachment to the lung. Most of the sleeve and captured tissue are then resected. What remains is a compressed cylinder of tissue on the surface of the lung.

The company plans to evaluate the product in clinical trials as a replacement for surgical staplers, staples, buttressing, and patching materials currently used for sealing lung tissue. The hopes to commercialize the product by late 2003.

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