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SPIRATION® VALVE SYSTEMFor the Treatment of Emphysema or Air Leaks.

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 fi ssures, or damaged lung

resulting in air leaks by limiting airfl ow to selected areas.

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

On inhalation, the Spiration Valve conforms to the airway and redirects air

to healthier tissues of the lung.

On exhalation, the Spiration Valve fl exibly constricts with the airways,

allowing trapped air and secretions to escape naturally along the bronchial

wall between the umbrella struts.

Removable

The fi rst and only

valve with anchors

for 0% migration and

expectoration. 2,14,15

The fi rst and only

valve with a center rod

to facilitate removal.

The fi rst and only valve with

umbrella struts to minimize tissue

contact and allow secretions

to escape naturally along the

bronchial wall.

Catheters for 2.0mm and 2.6mm

working channels.

5mm

10mm

8mm

6mm

11mm

9mm

7mm

12mm

10mm

9mm

12mm

12mm

Stays in Place

Greater Airway Access

Largest Range of Valve Sizes

Now available in 9mm size for large airways.

Redirects Air

THE CONFIDENCE YOU NEED FOR THE OUTCOMES YOU WANT.· Target lobe will have severe, highly heterogeneous emphysema with complete fissures. 1,2,3

· 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. 3

FOR THE TREATMENT OF EMPHYSEMA

From reliable, non invasive evidence of low collateral

ventilation...

SeleCT enables clinicians to submit HRCTs and receive quantitative

measures of fi ssure integrity.

· More accurate and reproducible than visual CT analysis. 16

· Comparable accuracy to Chartis. 16

· Avoids an invasive procedure just to confirm collateral ventilation. 16

· Not dependent on anatomy, coughing, or mucus where direct

bronchoscopic measure may be unreliable or not possible. 16

· Provides useful measures beyond complete fissures such as

emphysema severity, heterogeneity and lobar volume that may

improve the prediction of lung volume reduction. 16

...to 0% migration or expectoration 2,14,15 for effective lobar

occlusion

Complete occlusion is a prerequisite for signifi cant volume reduction,

which correlates with improvement in clinical outcomes.17

· FEV1 was improved by 21.4% at 90 days, with statistically significant

differences also seen across IVC, RV, RV/TLC, 6MWD, mMRC, SGRQ,

BODE and ADO. 17

· 99% technical success. 2,14

· Now available in 9mm size for large airways.

by

THE RIGHT PATIENT. THE RIGHT PRODUCT. THE RIGHT OUTCOMES.

THE PRECISION YOU NEED FOR THE OUTCOMES YOU WANT.· Persistent air leaks impact inpatient and outpatient resources utilization, cost, and morbidity. 4,5,6,7

· An air leak present by day 5 should be considered for thoracic surgical consultation or treatment. 5,8,9,10

· 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. 9,11,12,13

THE PRECISION YOU NEED FOR THE OUTCOMES YOU WANT.THE PRECISION YOU NEED FOR THE OUTCOMES YOU WANT.

FOR THE TREATMENT OF AIR LEAKS

A proven isolation technique9,18 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.*

...to 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.12,13,18

· 100% (n=9/9) of treated patients met the primary endpoint, as

identified as air leak cessation allowing chest tube removal. 13

· 77% (n=10/13) of treated patients were responders, as identified

as successful chest tube removal without the need for further

interventions. 12

· 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. 18

Reassess

Spiration Isolation Method

*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.

THE RIGHT PATIENT. THE RIGHT PRODUCT. THE RIGHT OUTCOMES.

Copyright © 2015 Spiration, Inc. d/b/a Olympus Respiratory AmericaARTG Identifiers: 188455, 182553, 181950

WAND Reference Nos: 110725-WAND-6BJ53E, 110505-WAND-6B1TDA, 110509-WAND-6B2O34

OLYMPUS EUROPA SE & CO. KGWendenstrasse 14-18, 20097 Hamburg, Germany

KEYMED LTD.KeyMed House, Stock Road, Southend-on-Sea, Essex, SS2 5QH, UK

OLYMPUS AUSTRALIA PTY. LTD.3 Acacia Place, Notting Hill, VIC 3168 Australia

OLYMPUS RESPIRATORY AMERICA6675 185th Ave NE, Redmond, Washington 98052 USA

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SPIRATION VALVE SYSTEM TECHNOLOGY

References

1. Scuriba. NEJM 2010; 363: 1233-1244. 2. Springmeyer. Thorac Surg Clin 2009; 19(2):247-253.3. Eberhardt. Chest 2012; 142(4): 900-908.4. Brunelli. Ann Thorac Surg 2004; 77:1205-1210.5. Schoenenberger. Arch Surg 1991; Vol 126.6. Varela. Eur J Cardiothoracic Surg 2005; 27:329-33.7. Brunelli. Chest 2006; 130:1150-6. 8. Cerfolio. Ann Thorac Surg 1998; 66: 1726-1730.9. Mahajan. J Thorac Cardiovasc Surg 2013; 145:626-630. 10. Yarmos. Chest 2012; 141(4):1098-105.11. Instructions for use, Humanitarian Use Device (HDE), Spiration Valve System.12. Firlinger. Ann Thorac Surg 2013 Apr; 95(4):1243-9.13. Dooms. Eur Respir J Epub Nov 14, 2013; doi: 10.1183/09031936.00117613. 14. Elstad. Am J Respir Crit Care Med 2012; 185:A1112.15. Ninane. Eur Respir J 2012; 39:1319–1325.16. Schuhmann. Am J Respir Crit Care Med 2015; Jan 30 [Epub ahead of print]; doi: 10.1164/rccm.201407-1205OC.17. Eberhardt. Chest Epub March 29, 2012; doi:10.1378/chest.11-2886.18. Gillespie. Ann Thorac Surg 2011; 91:270-3.

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 locationsIBV-V6 N3495430 6mm Yellow

IBV-V7 N3495530 7mm Green

IBV-V9 N5381200 9mm 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