Spiration® Valve System for Emphysema

The Right Patient. The Right Valve. The Right Outcomes.

The Spiration Valve System is an innovative endobronchial therapy that offers patients with severe emphysema a customized, minimally invasive treatment option for lung volume reduction with a favorable risk-benefit profile. Patients treated with the Spiration Valve System in clinical trials experienced improvements in breathlessness, lung function, and quality of life.1

The Right Patient
SeleCT® | The Key to Successful Patient Outcomes


Proper patient selection is crucial for the success of endobronchial valve treatment to achieve a good response to therapy. SeleCT is an artificial intelligence (AI) based patient screening platform using a quantitative CT analysis service that is completely non-invasive and offers not only rapid results but also includes a qualified overread by a trained medical professional. This solution makes additional, more invasive assessment tests unnecessary.

Key quantitative measures to identify responders for the Spiration Valve System:

Emphysema Severity

Allow physicians to quickly identify the most diseased lobe.

Heterogeneity

Differentiates target and ipsilateral lobe emphysema to facilitate redirection of ventilation to healthier tissue.

Fissure Integrity

EMPROVE trial results confirmed radiographic assessment of fissure completeness to be a reliable surrogate for collateral ventilation.

The Right Valve
How the Spiration Valve Works


The unique umbrella-shaped design of the Spiration Valve redirects air from diseased parts of the lung to healthier parts, all while allowing trapped air and secretions to escape naturally along the airway wall, so that patients may breathe easier.

Spiration Valve System: Emphysema Animation

Why Choose the Spiration Valve System?


A Decade of Clinical Experience

The Spiration Valve System has been available in the US Market, since 2008, under a Humanitarian Device Exemption (HDE) FDA approval, for the management of post-surgical prolonged air leaks. Physicians continue to choose the Spiration Valve System for emphysema treatment because of their trust and familiarity of the product after years of clinical practice with air leaks.

Jason A. Stienecker, DO
I choose the Spiration Valve System because I have experience with it. I know how it works, how to deploy it, how it sits, and how to take it out, if necessary.”
– Jason A. Stienecker, DO

Confidence in Valve Placement

The Spiration Valve System anchor design allows for more flexibility as to where to deploy the valves, independent of airway depth or access to a carina. This unique valve minimizes contact with the bronchial wall, maintains position to redirect air even in complex airways and facilitates removal when needed.

I really appreciate the elegance and the design of the Spiration Valves.”
– Kirk G. Voelker, MD
Video featuring Kirk G. Voelker, MD

Potential complications which may be associated with bronchoscopy and/or the Spiration Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, pneumonia, dyspnea and in rare cases, death. Prior to using the Spiration Valve System, please review the full list of prescriptive information at https://svs.olympusamerica.com/prescriptive-information for additional information on indications, contraindications, warnings, precautions and potential complications.


The Right Outcomes
Benefits That Make an Impact on Patient Lives


The EMPROVE Clinical Trial demonstrated the Spiration Valve System is a safe and effective treatment option for patients with severe emphysema and little-to-no collateral ventilation.1

STRONG RISK-BENEFIT PROFILE

Low 14.2% rate of serious pneumothorax

Short 24 min. procedure time which may reduce the risk of serious adverse events1,5

EFFECTIVE TARGET LOBE VOLUME REDUCTION

52.8% reduction of the target lobe volume

DECREASED HYPERINFLATION

6.3% reduction in hyperinflation

As measured by RV/TLC ratio

IMPROVED LUNG FUNCTION

12.1% significant increase in FEV1

REDUCES SHORTNESS OF BREATH

29.6% decrease in dyspnea

as determined by mMRC score

BETTER QUALITY OF LIFE

9.5 point reduction in SGRQ* score

Demonstrating a substantial and clinically-meaningful improvement

*A negative charge in SGRQ represents an improvement in disease specific health status. A 4 point reduction is considered clinically meaningful.
Dr. Gerard J. Criner, MD, FACP, FACCP
Recent clinical trials have shown that endobronchial valve treatment is going to become part of the standard of care in patients with advanced emphysema and hyperinflation.”
– Dr. Gerard J. Criner, MD, FACP, FACCP

Potential complications which may be associated with bronchoscopy and/or the Spiration Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, pneumonia, dyspnea and in rare cases, death. Prior to using the Spiration Valve System, please review the full list of prescriptive information at https://svs.olympusamerica.com/prescriptive-information for additional information on indications, contraindications, warnings, precautions and potential complications.

Recommended by GOLD


The Spiration Valve System received an Evidence A Rating from the Global Initiative for Chronic Obstructive Lung Disease (GOLD)2, affirming that endobronchial valves are a viable minimally invasive treatment option for severe emphysema.

Alpha-1 Antitrypsin Deficiency
The Only Valve Indicated for this Genetic Condition


Alpha-1 antitrypsin deficiency is a genetic condition and can often result in Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema symptoms in patients of any age. The Spiration Valve has been studied and shown to benefit these patients. Spiration Valve placement resulted in improvements in lung function, quality of life, and shortness of breath.1

  • Improvement in
    Lung Function
  • Target Lobe
    Volume Reduction
  • Improvements in Health Status, Dyspnea
    and COPD Assessment
Video featuring Jennifer W. Toth, MD and Michael F. Reed, MD
We have seen significant improvements in quality of life for patients with Alpha-1 antitrypsin deficiency that undergo Bronchoscopic Lung Volume Reduction with the Spiration Valve System.”
– Jennifer W. Toth, MD & Michael F. Reed, MD

Potential complications which may be associated with bronchoscopy and/or the Spiration Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, pneumonia, dyspnea and in rare cases, death. Prior to using the Spiration Valve System, please review the full list of prescriptive information at https://svs.olympusamerica.com/prescriptive-information for additional information on indications, contraindications, warnings, precautions and potential complications.

Patient Stories
Real Results from Real Patients


“[This procedure] is marvelous. It changes your life…it is a second chance at life.”

Watch Lucie’s Story  

“A few days afterwards, I started feeling normal again, like a mother, a grandmother, and just getting back to doing things that I love to do.”

Watch Marion’s Story  

“I can walk up the stairs, and I’m not out of breath so frequently. I had a major improvement on my life.”

Watch Ronny’s Story  

“The term ‘life-changing’ comes to mind. At least for me, I’ve gotten a lot back that I had lost.”

Watch Chris and Jodi’s Story  

Potential complications which may be associated with bronchoscopy and/or the Spiration Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, pneumonia, dyspnea and in rare cases, death. Prior to using the Spiration Valve System, please review the full list of prescriptive information at https://svs.olympusamerica.com/prescriptive-information for additional information on indications, contraindications, warnings, precautions and potential complications.

Frequently Asked Questions


EMPROVE Clinical Trial
SeleCT Patient Selection Analysis
REACH Clinical Trial
Alpha-1 Antitrypsin EMPROVE Study
Procedure Overview
Reimbursement
1. Kon SS, et al. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3.
2. Gompelmann D, et al. Respiration. 2019;97(2):145-152. doi: 10.1159/000492274.
3. Li S, et al. Respiration. 2018:1-12. doi:10.1159/000494327
  1. Criner GJ et al., 2019 Improving Lung Function in Severe Heterogenous Emphysema with the Spiration® Valve System (EMPROVE): A mliticenter, Open-Label, Randomized, Controlled Trial. Am J Respir Crit Care Med, 2019. https://doi.org/10.1164/rccm.201902-0383OC
  2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of COPD, 2019. http://golcopd.org
  3. https://www.nice.org.uk/guidance/ipg600/resources/endobronchial-valve-insertion-to-reduce-lung-volume-inemphysema-pdf-1899873854992069. Accessed 2018.
  4. Slebos DJ, Shah PL, Herth FJ, et al. Endobronchial Valves for Endoscopic Lung Volume Reduction: Best Practice Recommendations from Expert Panel on Endoscopic Lung Volume Reduction. Respiration. 2017;93(2):138-150.
  5. Schuhmann M, Raffy P, Yi Y, et al. CT Predictors of Response to Endobronchial Valve Lung Reduction Treatment: Comparison with Chartis. Am J Respir Crit Care Med 2015; 191(7):767-774; doi:10.1164/rccm.201407-1205OC.
  6. Hogarth DK, Delage A, Zgoda MA, Reed MF. American Thoracic Society International Conference Abstracts. American Thoracic Society; 2018:A7754-A7754. doi:10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7754.
  7. Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014;21(4):288-297. doi:10.1097/LBR.0000000000000110.
  • Criteria to determine eligible patients for the treatment are based upon findings established by the EMPROVE clinical trial. These recommendations are not meant to replace patient-specific clinical judgement.  SeleCT report should not be considered a complete radiological analysis.
  • Gerard Criner, MD, FACP, FACCP, the authoring physician of this video, is a paid consultant to Olympus Corporation of the Americas.
  • Kirk G. Voelker, MD, the authoring physician of this video, is a paid consultant to Olympus Corporation of the Americas. Spiration is a registered trademark of Olympus Respiratory America.
  • Jason Steinecker, DO, the authoring physician of this presentation, is a paid consultant to Olympus Corporation of the Americas.
  • Michael Reed, MD and Jennifer Toth, MD, the authoring physicians of this presentation, are paid consultants to Olympus Corporation of the Americas.