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New Products In Brief

This article was originally published in The Gray Sheet

Executive Summary

Spiration IBV lung valve approved for post-surgical air leaks: Removable bronchial valve implant gains FDA humanitarian device exemption (HDE) approval Oct. 24 to treat prolonged air leaks that last at least seven days after a lobectomy, segmentectomy, or lung volume reduction surgery. The valve, which is inserted using a bronchoscope and intended to be removed within six weeks, allows air to flow in only one direction, preventing it from entering the affected areas but allowing air and mucus to escape, according to FDA. The device "may ease post-operative recovery," states Daniel Schultz, director of FDA's device center. The agency's HDE approval process is intended for devices that diagnose or treat conditions affecting less than 4,000 U.S. patients annually. Privately held, Redmond, Wash.-based Spiration notes that it also is conducting a pivotal study of the device for severe emphysema (1"The Gray Sheet" April 14, 2008, p. 10)

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Olympus inhales Spiration

Pulmonary device maker Spiration is acquired by bronchoscope maker Olympus for undisclosed terms in a deal announced June 25. Spiration's IBV removable bronchial valve implant gained FDA humanitarian device exemption (HDE) approval in 2008 to treat prolonged air leaks following certain lung surgeries (1"The Gray Sheet" Nov. 3, 2008). A pivotal study of the device for severe emphysema is ongoing. "We will take advantage of the synergies of the two companies in our development of next-generation endoscopic respiratory products," Olympus said

Olympus inhales Spiration

Pulmonary device maker Spiration is acquired by bronchoscope maker Olympus for undisclosed terms in a deal announced June 25. Spiration's IBV removable bronchial valve implant gained FDA humanitarian device exemption (HDE) approval in 2008 to treat prolonged air leaks following certain lung surgeries (1"The Gray Sheet" Nov. 3, 2008). A pivotal study of the device for severe emphysema is ongoing. "We will take advantage of the synergies of the two companies in our development of next-generation endoscopic respiratory products," Olympus said

Lung Valve Device Wins Medicare Inpatient Add-On Payment

The Spiration IBV Valve System is the only product to gain a new technology add-on payment from CMS under the 2010 inpatient prospective payment system rule released July 31

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