Engineered For Airway Management

Inspired by aerodynamics, the Spiration Valve redirects air away from diseased or damaged lung to healthier tissue, all while allowing trapped air and secretions to escape, so that patients may breathe easier.

Unlike a stent, the unique design of the Spiration Valve minimizes contact with the bronchial wall, maintains position to redirect air even in complex patients, and facilitates removal when needed. 

The Spiration Valve System is intended to treat severely diseased lung in patients with heterogeneous emphysema and evidence or markers of low collateral ventilation such as complete fissures, or damaged lung resulting in air leaks by limiting airflow to selected areas. 

The procedure is considered minimally invasive and can be performed through a flexible bronchoscope.

  

Redirecting Air Flow

Persistent air leaks continue to be a leading cause of increased hospitalization, morbidity and cost. Traditional management of persistent leaks involves chest drainage and observation followed by more invasive treatments when leaks do not resolve.1, 2, 3

Traditional “wait and see” approaches can lead to increased length of stay (LOS) and frustration for both the provider and patient.1, 2 The Spiration Valve System is minimally invasive procedure that provides surgeons and pulmonologists a predictable method for limiting distal airflow to diseased lung. It is a proactive option in the management of persistent air leaks.4, 5

On inhalation, the Spiration Valve conforms to the airway and redirects air to healthier tissues of the lung.

 

On exhalation, the Spiration Valve flexibly constricts with the airways, allowing trapped air and secretions to escape naturally along the bronchial wall between the umbrella struts.

 

Inspiration Meets Innovation

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.

The valve consists of a Nitinol frame covered with a polymer membrane and five anchors that securely engage the airway walls at the targeted treatment location. Once in place, the Spiration Valve limits airflow to damaged tissue while allowing trapped air and fluid to escape. A reduction in air flow to damaged lung has been shown to accelerate resolution of an air leak. Because air leaks are transient in nature, the Spiration Valve was designed to be removed upon resolution of the leak.4

 

Stays in Place
The first and only valve with anchors for
0% migration and expectoration6, 7, 8
Greater Airway Access
Catheters for 2.0mm and 2.6mm
working channels
Redirects Air
The first and only valve without a pressure
fit, allowing secretions to escape naturally
along the bronchial wall
Removable
The first and only valve with a center
rod to facilitate removal

 

Largest Range of Valve Sizes

Now available in 9mm size for large airways.

 

Spiration Valve System Technology

Deployment Catheter and Loader

Model Name

Article Number

Catheter Working Length

Bronchoscope Channel Inner Diameter

Valve Size Compatibility

IBV-C26N

N5381300

1020mm

2.6mm or greater

For 5, 6, 7 and 9mm Valves

IBV-C20

N3521830

1140mm

2.0mm or greater

For 5, 6 and 7mm Valves

 

Spiration Valves

Model Name

Article Number

Valve Size

Cartridge Color

Number Required Per Procedure

IBV-V5

N3495330

5mm

Blue

Determined by number of target locations

IBV-V6

N3495430

6mm

Yellow

IBV-V7

N3495530

7mm

Green

IBV-V9

N5381200

8mm

Grey

 

Airway Sizing Kit

Model Name

Article Number

Gauge Hole

Glass Syringe

Number Required Per Procedure

IBV-VSK

N5534500

Sized for appropriate
valve selection

500 microliters

1

 

Required Ancillary Equipment Needed for Each Procedure

  • Flexible bronchoscope with a working channel inner diameter of 2.0mm or greater
  • Olympus balloon catheter B5-2C
  • Bronchoscopy forceps appropriate for valve removal
  • Standard 10cc sterile syringe with Luer-lock for use in preparing the balloon catheter
  • Sterile saline

 

Learn More

  • CLICK HERE to learn more about the minimally invasive procedure
  • CLICK HERE for information on the clinical studies supporting the use of bronchial valves for the treatment of air leaks

FOOTNOTES

  1. 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
  2. Stolz AJ, Schutzner J, et al. Predictors of prolonged air leak following pulmonary lobectomy. Eur J Cariothorac Surg 2005;27:334-336.
  3. Wood DE, Cerfolio RJ, Gonzalez et al. Bronchoscopic management of prolonged air leak. Clin Chest Med 31 2010;127-133.
  4. Instructions for Use, IBV Valve System, HUD
  5. 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.
  6. Springmeyer. Thorac Surg Clin 2009; 19(2):247-253.
  7. Elstad. Am J Respir Crit Care Med 2012; 185:A1112.
  8. Ninane. Eur Respir J 2012; 39:1319–1325.