In the United States:

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.

  • Contraindications:  Patient is unable to tolerate a flexible bronchoscopy procedure.
  • Warnings: Atelectasis may occur after the air leak seals and patients should be monitored for this possible complication.
  • 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.
  • Potential Adverse Effects:  Atelectasis; Death; Infection in the tissue distal to a valve; Local airway swelling or edema at site of valve implantation; Pneumothorax.

For full prescribing information go to:  www.spiration.com/IFU

FDA HDE Approval Documents:
http://www.clinicaltrials.gov/ct2/show/NCT01812447?term=emprove+spiration&rank=1

CAUTION:  Investigational device. Limited by Federal (or United States) law to investigational use.  The Spiration Valve System is not approved for use in emphysema in the U.S. but is subject to ongoing clinical investigation in which approval for use in emphysema will be sought. 


Europe, Australia, New Zealand:

 The Spiration, Inc. IBV Valve System has received market clearance  in select countries  to treat severely diseased lung in patients with heterogeneous emphysema with evidence or markers of low collateral ventilation such as complete fissures, or damaged lung resulting in air leaks, by limiting airflow to selected areas.


ARTG Identifiers: 188455, 182553, 181950
WAND Reference Nos: 110725-WAND-6BJ53E, 110505-WAND-6B1TDA, 110509-WAND-6B2O34