For the Treatment of Emphysema

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 by limiting airflow to selected areas.

A minimally invasive solution for the treatment of severe emphysema

  • 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 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. 
  • 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 for the management of pneumothorax.2

Spiration Valve System treatment benefits may include1

  • Reduction in hyperinflation
  • Improvements in pulmonary function as indicated by an improvement in FEV1
  • Improved exercise tolerance
  • Improved quality of life as measured by SGRQ

The right patient. The right product. The right outcomes. 

  • Target lobe will have severe, highly heterogeneous emphysema with complete fissures.1
  • Multiple valves are placed to occlude all the airways leading to the targeted lobe and enable atelectasis or significant lobar reduction.
  • Significant lobar reduction can relieve hyperinflation, enable healthier tissue to expand, and make breathing easier.1  

The valve redirects air to healthier parts of the lung and reduces over-inflation.

 

More than one valve will be placed. The valve allows trapped air and fluids to flow past it, but blocks air from entering the diseased part of the lung.

 

 

The Confidence You Need For The Outcomes You Want

 

Stays in Place
The first and only valve with anchors
for 0% expectoration 2, 4, 5
Greater Airway Access
More Flexibility as to where to place
valve. Anchors can be in a separate
airway than where sealing is.
Redirects Air
The first and only valve with umbrella struts
to minimize tissue contact and allow secretions
to escape naturally along the bronchial wall.
Removable
The first and only valve
designed to facilitate removal.

 

 

Largest Range of Valve Sizes

Available in four sizes to allow occlusion in proximal and distal airways.

 

Spiration Valve System Technology

Spiration Valves

Catalog Number

Valve in Cartridge

Cartridge Color

IBV-V5

5mm

Blue

IBV-V6

6mm

Yellow

IBV-V7

7mm

Green

IBV-V9

8mm

Grey

Airway Sizing Kit

Catalog Number

   Kit Includes

IBV-VSK

   500 microliter glass syringe with a plunger,
a calibration gauge, and a sizing worksheet

B5-2C

   1 Olympus B5-2C Disposable Balloon Catheter

Deployment Catheter and Loader

Catalog Number

             Bronchoscope Working Channel

IBV-C26N

             2.6mm or greater inner diameter

IBV-C20

             2.0mm or greater

 

             Deployment Catheter Length

IBV-C26N

             1020mm

IBV-C20

             1140mm

Ancillary equipment needed for each procedure

  • Flexible therapeutic bronchoscope with a working channel inner diameter of 2.6mm or greater 
  • Bronchoscopy forceps appropriate for valve removal
  • Standard 10cc sterile syringe with Luer-lock
  • Sterile saline (approximately 15–30cc used per procedure)
  • A balloon catheter that inflates to 13mm or larger (for balloon occlusion only)

 

Learn More

  • CLICK HERE to learn more about selecting appropriate patients that may benefit from the Spiration Valve System
  • 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 emphsyema

FOOTNOTES

  1. Eberhardt R, Gompelmann D, Schuhmann M, et al. Complete Unilateral vs Partial Bilateral Endoscopic Lung Volume Reduction in Patients With Bilateral Lung Emphysema.  Chest 2012;142(4):900-908; doi:10.1378/chest.11-2886
  2. Springmeyer S, Bolliger C, Waddell K, et al. Treatment of Heterogeneous Emphysema Using the Spiration IBV Valves. Thorac Surg Clin 2009; 19:247-253
  3. Sciurba FC, Ernst AE, Herth FJF, et al. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med 2010:363: 1233-44
  4. Elstad. Am J Respir Crit Care Med 2012; 185:A1112.
  5. Ninane. Eur Respir J 2012; 39:1319–1325.