The Precision You Need
For The Outcomes You Want.

  • Persistent air leaks impact inpatient and outpatient resources utilization, cost, and morbidity. 1,2,3,4 

  • An air leak present by day 5 should be considered for thoracic surgical consultation or treatment. 2,5,6,7

  • A substantial reduction in an air leak using Spiration Valves may accelerate the resolution of an air leak. Complete cessation of an air leak may not be achievable, or necessary, for successful treatment. 6,8,9,10

 

A proven isolation technique6,12 to identify the source of air leak(s)...

From the leader in valve therapy for air leaks with over two thousand procedures supported worldwide.

1. Assess

Block main bronchus to determine if the leak can be stopped or reduced and the length of time it takes to see a change in the water seal monitor.

2. Isolate

Systematically work from proximal to distal. 

3. Place Valve

Once an airway is identified, size the airway and place a valve.

4. Reassess

Repeat process to isolate additional leaks as dynamics may have changed since valve placement.* 

*Treatment should be limited to no more than 3 segments by placing valves in segmental or sub-segmental bronchi in the target lung to avoid excessive isolation of tissues from ventilation. 

 


A Minimally Invasive Treatment for Air Leaks

Using endobronchial techniques, the Spiration Valve System enables qualified physicians to predictably place the valves in pre-identified airways to aid in the reduction or cessation of persistent leaks. The Spiration Valve System flexible catheter is specially designed to help physicians navigate and deploy the Spiration Valves in segmental and subsegmental airways allowing for preservation of healthy tissue. The Spiration Valve procedure is performed under conscious sedation or general anesthesia.11

Prior to valve placement, it is necessary to isolate and target the culprit airways contributing to the leak. The source and number of air leaks will vary considerably between patients due to changing lung dynamics. It is recommended to begin isolation wtih balloon occlusion at the main bronchus, moving from proximal to distal airways until a culprit leak is isolated.11

Once a valve has been placed, any additional leaks should be located by returning to the main bronchus, and moving from proximal to distal airways. Previously tested airways that showed no evidence of an air leak before a valve was placed may now be visualized in the air leak monitor. 

Within a few weeks of the air leak being resolved, the valve(s) may be removed using bronchoscopic techniques and forceps. The unique design of the Spiration Valve has a center removal rod, which facilitates its removal as needed.

 

Spiration Valve Procedure for Air Leaks

 

Balloon Calibration

Prior to the procedure, a sizing balloon is calibrated to enable precise measurement of the airways.

 

 

 

Airway Isolation


Successful isolation requires systematic movement from proximal to distal airways.

 

 

Airway Sizing

The calibrated balloon is used to determine the appropriate valve size for placement.

 

 

Valve Removal

Valves are removed using bronchoscopic techniques and biopsy forceps.

 

 

 

...for a minimally invasive solution with a center rod to facilitate removal upon resolution of the air leak.

Treatment with the Spiration Valve System has demonstrated a favorable responder rate.9,10,12

  • 100% (n=9/9) of treated patients met the primary endpoint, as identified as air leak cessation allowing chest tube removal.10

  • 77% (n=10/13) of treated patients were responders, as identified as successful chest tube removal without the need for further interventions.9

  • 100% (n=7/7) of treated patients had improvement in the air leak, as defined as improvement allowing Heimlich valve use, improvement of 1 Cerfolio classification, or complete cessation of the air leak.12

 

Learn More

  • CLICK HERE about the state-of-the-art design of the Spiration Valve System
  • CLICK HERE for information on the clinical studies supporting the use of bronchial valves for the treatment of air leaks

FOOTNOTES

  1. Brunelli. Ann Thorac Surg 2004; 77:1205-1210.
  2. Schoenenberger. Arch Surg 1991; Vol 126.
  3. Varela. Eur J Cardiothoracic Surg 2005; 27:329-33.
  4. Brunelli. Chest 2006; 130:1150-6. 
  5. Cerfolio. Ann Thorac Surg 1998; 66: 1726-1730.
  6. Mahajan. J Thorac Cardiovasc Surg 2013; 145:626-630. 
  7. Yarmos. Chest 2012; 141(4):1098-105.
  8. Instructions for use, Humanitarian Use Device (HDE), Spiration Valve System.
  9. Firlinger. Ann Thorac Surg 2013 Apr; 95(4):1243-9.
  10. Dooms. Eur Respir J Epub Nov 14, 2013; doi: 10.1183/09031936.00117613. 
  11. Mahajan AK, Doeing DC, Hogarth DK et al. Isolation of persistent leaks and placement of intrabronchial valves. J Thorac Cardiovasc Surg 2013;145:626-30.
  12. Gillespie. Ann Thorac Surg 2011; 91:270-3.