December 14, 2010 | The Bulletin

Chief executive says approval is ‘major milestone’

By Tim Doran / The Bulletin

Published:December 14. 2010 4:00AM PST

Bend-based Clear Catheter Systems has received U.S.Food and Drug Administration clearance to market its catheter-clearing devicein the United States,the world’s largest medical device market.

“This is a major milestone for a medical deviceproduct,” Dr. Ed Boyle, CEO of Clear Catheter Systems, said Monday from Cleveland. “Gettingclearance in the United States is a big deal.”

The PleuraFlow System works with chest tubes afterheart and lung surgery. A clogged chest tube can lead to complications, andpossibly even death, according to a news release.

The PleuraFlow System uses a proprietary method tokeep the tubes clear, which can help reduce surgery risks and complicationsand, by extension, costs, according to the news release.

Boyle and Andrew Firlik, a neurologist and venturecapitalist, founded Clear Catheter. The company won the top investment prize inthe 2006 Bend Venture Conference, and earlier this year received $1.2 millionin equity financing from the Oregon Angel Fund and other investors.

In 2007, it joined with a branch of the ClevelandClinic and later opened an office in Ohio.

The PleuraFlow Catheter System had previouslyreceived approval for use in Canadaand Europe, but approval in the U.S.means access to the world’s largest medical device market, which was valued in2008 at more than $100 billion, or 42 percent of the world’s total, accordingto the International Trade Administration, an arm of the U.S. CommerceDepartment.

For Clear Catheter Systems, the next milestone willbe how well the medical industry receives the PleuraFlow system, Boyle said.Early reviews have been promising, and the product has been generatinginterest.

Along with support from investors, the system wonthe 2009 European Association of Cardio-Thoracic Surgery Techno CollegeInnovation Award.

An Arizonacompany that specializes in manufacturing medical devices makes the PleuraFlowCatheter System.

When asked if manufacturing might move to Central Oregon, Boyle said, “It’s possible.”

But, he said, all will depend on the device’sadoption by the industry.

Tim Doran can be reached at541-383-0360 or at [email protected]