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Summary of Clinical Data

Prior to FDA approval being granted for the Spiration® Valve System in the control of prolonged air leaks, a series of four "compassionate use" patient cases1 were submitted to the FDA. "Compassionate use" refers to special approval by the FDA for use of a device in an individual patient when no other treatment is available.

Sixteen Spiration valves were placed across the four patients. All four patients had an immediate decrease or end to their air leak. No problems related to the device were reported. See below for a summary of events associated with the procedure.

Table 1: Procedure-Related Problems in Compassionate Use Patients

Adverse Event   Comments
Inflamed tissue 1 out of 4 patients and 16 valves During the procedure to remove the valves, a very small amount of airway tissue inflammation was seen.
Ventilator support 1 out of 4 patients After the procedure, a patient required assistance with breathing (mechanical ventilation) for less than 24 hours.

 

 

FOOTNOTES

  1. Data on file.