a. CAUTION: Humanitarian Device. Authorized by Federal law for use in the control of prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or Lung Volume Reduction Surgery (LVRS). The effectiveness of this device for this use has not been demonstrated. Federal law restricts this device to sale by or on the order of a physician.
i. Contraindications: Patient is unable to tolerate a flexible bronchoscopy procedure.
ii. Warnings: Atelectasis may occur after the air leak seals and patients should be monitored for this possible complication.
iii. General Precautions: The Spiration Valve System should not be used for patients who have active asthma, bronchitis or clinically significant bronchiectasis. Only use a bronchoscope with a working channel of 2.6mm or larger. Do not use the Spiration Valve System for other than its intended use.
iv. Potential Adverse Effects: Atelectasis; Death; Infection in the tissue distal to a valve; Local airway swelling or edema at site of valve implantation; Pneumothorax.
b. The information in this section is for health care professionals licensed to practice in the United States. This information should not be considered medical advice regarding a specific patient or patient type. Each health care professional who accesses this site retains sole responsibility for decisions regarding patient care. Please review the instructions for use for important safety information and other product information.