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Angle, move up a millimeter, reposition, measure. Finally Mortman picks a spot. An assistant gently moves a plunger to unfold the valve -- but it springs out of place. The airway was too tight a squeeze. Mortman pulls out the valve and finds a better position.
Try No. 2 doesn't unfold correctly. A Spiration representative, watching in case Mortman seeks advice, will send it back to company engineers to see why.
Mortman's third try hooks into place. Swinging the catheter into an adjoining airway, Mortman then hooks in another valve to seal off that direction, too. It will take a few weeks to tell if the leak finally heals, but Vance goes home the next day, breathing OK.
How often do these valves succeed? That's not yet clear. The Food and Drug Administration approved "humanitarian use" of the IBV valve for prolonged surgical air leaks -- an option that lets promising novel options for rare conditions sell, with some profit restrictions, before large effectiveness studies are done. With a shorter hospital stay, it's cheaper than air-leak surgery, yet prominent IBV researcher Dr. Robert Cerfolio of the University of Alabama at Birmingham said few doctors know about the option.
Temple University researchers last fall published outcomes of 40 patients implanted with a similar but still experimental valve now owned by competitor Pulmonx Inc., and found nearly 48 percent had their leak completely sealed and most of the rest improved.
But both companies have a bigger aim: To treat advanced emphysema by redirecting air from scarred lung spots and into healthier areas of the lung. Spiration's emphysema study is ongoing; Pulmonx has clearance to sell its valve in parts of Europe and is preparing for a U.S. study.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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