Air Leaks

Air Leaks
Spiration® Valve System

For Management of Post-surgical Prolonged Air Leaks

Since 2008, the Spiration® Valve System is the first and only FDA approved endobronchial valve for management of post-surgical prolonged air leaks*. Over the past decade, the body of clinical evidence continues to grow for the use of endobronchial valves in management of post-surgical air leaks. The Spiration Valve bronchoscopic procedure has proven to be a feasible, effective, and safe approach that can favorably affect the course of patients with post-pulmonary resection air leaks.1

Patients treated with the Spiration® Valve System spent a median of four days in the hospital post-treatment, with 93.8% of treated patients having a positive response.1

ENDOBRONCHIAL VALVE TREATMENT

FOR PROLONGED AIR LEAK MANAGEMENT

Post-surgical air leaks continue to be the most common complication following surgical resection and a leading cause of increased hospitalization, morbidity, and cost. Traditional management of prolonged leaks involves chest drainage and observation, followed by more invasive treatments when leaks do not resolve.2,3,4

Traditional “wait and see” approaches can lead to increased length of stay and frustration for both the provider and patient.2,3 The Spiration Valve System procedure is minimally invasive and provides surgeons and pulmonologists a novel method for limiting distal airflow to damaged lung. It is a proactive option in the management of prolonged air leaks.5

The Spiration Valve limits airflow to damaged tissue all while allowing trapped air and secretions to escape naturally along the airway wall. A reduction in air flow to damaged lung has been shown to accelerate resolution of an air leak.1
 

SPIRATION VALVE SYSTEM

The Spiration Valve is an umbrella-shaped, one-way valve that is placed via a delivery catheter, introduced through the working channel of a flexible bronchoscope. Once in place, the Spiration Valve limits airflow to damaged tissue while allowing trapped air and fluid to escape.  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 Air leaks are transient in nature, so the Spiration Valve was designed to be removed upon resolution of the leak.7

Secure Valve Positioning

The first and only valve with anchors to prevent migration and expectoration.

Versatile Access

Anchor design allows more flexibility as to where to deploy valves independent of airway depth or access to a carina.

Minimal Tissue Contact

The first and only valve with an umbrella design to allow natural movement of air and mucus in the proximal direction.

Easy Valve Removal

The first and only valve designed to facilitate retrieval with 360° access to the removal rod.

Custom Fit

Multiple sizing options with 4 valve sizes ranging from 5mm – 9mm.

Airway Isolation Method

Airway Isolation Method - A systematic approach to locating and isolating air leaks is a critical step to successful treatment.

Assess
Block main bronchus to determine:
  1. If the leak can be stopped or reduced.
  2. Length of time it takes to see a change in the water seal monitor.
Isolate
Systematically work from proximal to distal:
  1. Occlude upper lobe — if no change,
  2. Move to the lower lobe(s),
  3. Once a target lobe is identified, test the individual sub-segments.
Place Valve
Once an airway is identified, place a valve.
Air Leak Resolved?
Yes = End
No = Reassess
Repeat process to isolate additional leaks as dynamics may have changed since valve placement.* Continue until all major and minor leaks have been identified.
Procedure Steps

Spiration Valve Procedure

Once an air leak location has been isolated, the airway will be sized and the valves placed. Once the air leak has resolved, it is recommended that the valves be removed.
 

Airleaks - Calibrated Balloon
A calibrated balloon is used to customize the appropriate valve size for placement.
Airleaks valve anchors
The Spriation Valve is delivered to the target site during a bronchoscopic procedure. The valve anchors are designed to maintain position and minimize expectoration.
Airleaks valve on inhalation
On inhalation, the Spiration Valve may stop or reduce the amount of air flowing to portions of lung with an air leak.
Valve facilitates retrieval
When valves are removed, the Spiration Valve is designed to facilitate retrieval with 360° access to removal rod.

Procedure Support

Airleak Procedure Support

Technical procedure support may be requested for post-surgical lobectomy, segmentectomy or lung volume reduction cases.

Request Support

*INDICATION FOR USE: The Spiration Valve System is a device to control 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). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Spiration Valve System use is limited to 6 weeks per prolonged, postoperative air leak.

CAUTION: Humanitarian Use Device for prolonged, postoperative Air Leaks. 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.

1 Abu-Hijleh M, Styrvoky K, Anand V, et al. lntrabronchial Valves for Air Leaks After Lobectomy, Segmentectomy, and Lung Volume Reduction Surgery. Lung, 2019: 197, 627-633.

2 Cerfolio RJ and Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg 2008;86:396-401.

3 Stolz AJ, Schutzner J, et al. Predictors of prolonged air leak following pulmonary lobectomy. Eur J Cariothorac Surg 2005;27:334-336.

4 Wood DE, Cerfolio RJ, Gonzalez et al. Bronchoscopic management of prolonged air leak. Clin Chest Med 31 2010 127-133.

5 Mahajan AK, Doeing DC, Hogarth DK. Isolation of persistent leaks and placement of intrabronchial valves. J Thorac Cardiovasc Surg 2013;145:626-30.

6 Dooms C, et al. Bronchial valve treatment for pulmonary air leak after anatomical lung resection for cancer. Eur Respir J 2014; 43: 1142-1148.

7 Instructions for Use, Spiration Valve System, HUD.