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
Were any patients in the EMPROVE trial discharged with a pneumothorax?
Yes. Of those patients, some may have been discharged with a chest tube (with or without a Heimlich valve) in-place awaiting resolution.
How many pneumothorax events were in the contralateral lobe?
5/33 cases (15%).
What was the average duration of chest tube time?
Not all patients with pneumothorax had a chest tube inserted and chest tube duration time was not recorded.
What was the average duration of hospitalization post PTX?
The mean duration (onset to resolution) for non-serious PTX events was 4.4 days (range 1 – 8 days). Serious PTX events (ones that required intervention/chest tube) generally took longer to resolve: mean duration 13.8 days (range 2 —37 days).
Were any valves removed for pneumothorax management?
Yes, one or more valves were removed in 11/16 (69%) patients with a serious pneumothorax and 2/13 (15%) of subjects with a non-serious pneumothorax. 2/28 (8%) patients needed to have all their valves removed to manage PTX (serious or non-serious).
How many pneumothoraces led to respiratory failure and/or pneumonia?
A total of 7 PTX events in 6 pts (5.3%) led to or were associated with pneumonia or respiratory failure:
  • Non-serious (Moderate) PTX led to Respiratory failure
  • Serious PTX. Pneumonia occurred 7 days later
  • Non-serious (Severe) PTX associated with pneumonia
  • Non-serious (Moderate) associated with respiratory failure
  • Serious PTX associated with respiratory failure
  • Non-serious (Moderate) led to pneumonia 7 days later
  • Serious PTX associated with pneumonia
What are the efficacy endpoint data by pneumothorax, serious pneumothorax, and no pneumothorax? Was this statistically significant?
Delta Baseline – 3 Months FEV1 (ml) mMRC (points) CAT (points) SGRQ (points)
Serious PTX (N=14) 129 ±222 -0.62 ±1.26 -4.3 ±7.5 -10.3 ±15.2
No PTX (N=99) 124 ±164 -0.49 ±0.96 -3.0 ±7.0 -8.2 ±17.8
P- value between groups 0.643 0.921 0.893 0.802
Is there a different pneumothorax rate in treated subjects who received 9mm valves?
There doesn’t appear to be a difference in PTX rate with 9mm valves.
UPPER LOBES 9mm valves only 9 + mix of valves No 9mm valves
Serious PTX 4/22 9/35 6/22
Non-serious PTX 3/22 2/35 1/22
LOWER LOBES 9mm valves only 9 + mix of valves No 9mm valve
Serious PTX 1/10 0/20 0/4
Non-serious PTX 1/10 6/20 0/4
ALL LOBES 9mm valves only 9 + mix of valves No 9mm valves
Serious PTX 5/32 9/55 6/26
Non-serious PTX 4/32 8/55 1/26
Were there any instances where patients experienced a “trapped lung” as opposed to a pneumothorax?
We are not aware of any EMPROVE subjects who experienced a “trapped lung.” Trapped lung is an instance where the lung does not fully expand during pleural drainage. When pneumothorax occurs after placement of an endobronchial valve, it is thought to be from the re-expansion of the ipsilateral lobe (the opposite of a trapped lung).
What value do you use as a cutoff for determining if a patient has pulmonary hypertension?
The EMPROVE trial determined pulmonary hypertension as having a pulmonary artery pressure greater than 45mmHg, as determined by echocardiogram. If echocardiogram was questionable, a right heart cath was used to make the final determination.
How often were patients in EMPROVE followed up?
Subjects were seen at the following intervals: 1 months, 3 months, 6 months, 12 months. Annual follow-up in the treatment arm will occur up to 5 years (treatment arm) and 2 years (control arm).
What is the average improvement in the COPD Assessment Test (CAT)1 score in EMPROVE?
Relative difference at 6 months was 4.5 and 5.3 at 12 months. MCID for the CAT is a 2-point improvement.
How many patients were on oxygen?
Supplemental oxygen use was similar between the two study groups with 45.1% of the treatment group and 45.8% of the control group using oxygen. Average at-rest oxygen flow rates were also equivalent (1.2 liters/min for both study groups).
How many patients were on low dose steroids?
81.4% of the treatment group and 84.7% of the control group.
How many patients received prophylactic antibiotics and steroids?
98% of SVS treatment patients received peri-procedural antibiotics. 57.5% of SVS treatment patients received peri-procedural steroids.
Was tissue hyperplasia and/or granulation seen in any of the EMPROVE subjects?
Some granulation was seen during re-bronchs of 11 subjects. The data provided in the training presentation is from our initial pilot experience. In our first 10 patients, there was a required re-bronch at one month.
Why were patients with a giant bulla excluded from EMPROVE?
Patients with giant bullae represent a different emphysema phenotype and the benefits may be different than that of the emphysema patient we are targeting for treatment.
Why didn’t EMPROVE have a lower limit for FEV1 and an upper limit for BMI? Should the physician consider having an upper/lower limit when selecting patients?
Patients with a very low FEV1 and high BMI may benefit, however they are complex. It was determined that screening patients for inclusion in the study using medical inclusion/exclusion criteria was more appropriate.
What was the percentage of patients treated in EMPROVE and LIBERATE who met the MCID for SGRQ and mMRC?
Measure MCID EMPROVE LIBERATE
SGRQ 4.0 points 50.5% 56.2%
mMRC 1.0 point 48.9% 47.8%
What is the outcome data on patients with 95-100% fissure vs. those with 90-94% fissure? Was there a difference?
The number of patients with fissure integrity < 95 is small, but there does appear to be a trend for patients with FI ≥ 95% to have better improvements.
Delta Baseline – 6 Months FEV1 (ml) TLV (L) RV (L) mMRC (points) SGRQ (points)
Fissure Integrity ≥95% (N=87) 112 ±159 -1.02 ±0.75 -0.49 ±0.85 -0.66 ±1.04 -9.5 ±16.7
Fissure Integrity 90-94% (N=19) 38 ±115 -0.74 ±0.60 -0.002 ±0.75 -0.58 ±1.02 -1.9 ±18.0
P- value between groups 0.0576 0.1607 0.0224 0.7601 0.0853
What was the median hospital stay for treated patients in EMPROVE?
The median hospital stay was one day.
Is there a statistically different rate in re-bronchs with patients who were treated in the lower lobe?
3/34 (8.8%) subjects with targeted lower lobes required rebronchs for valve adjustment, compared to 8/79 (10.1%) with targeted upper lobes. No significant difference.
Is there a mortality benefit? PulmonX claims that there is a mortality benefit with their valves. Does the SVS have the same mortality benefit?
The EMPROVE trial was not powered to assess for a mortality benefit. Both EMPROVE and the SVS post-approval study will assess mortality over a 5-year and 3-year follow-up, respectively, which may be sufficient to power an analysis of mortality benefit against historical controls.

PulmonX makes this claim based on a retrospective analysis of data collected by the Thoraxklinik in Heidelberg, Germany.2 The dataset for this analysis included both SVS and PulmonX Zephyr valves, so this is not strictly a PulmonX-only claim. As such, it is a bit disingenuous to claim a benefit of improved mortality based on a single, retrospective study, let alone a benefit tied to a specific valve, but the data is an encouraging signal that BLVR may be associated with improved mortality, independent of valve used.
What were the changes in PO2 and PCO2 over time?
There were no statistically significant differences between the control and treatment groups in the mean change at 3 or 6 months.
PO2 Treatment Control
Baseline 67.89 67.95
Delta at 3 months -2.34* 0.38
Delta at 6 months -1.80* 0.72
PCO2 Treatment Control
Baseline 40.16 40.94
Delta at 3 months -0.81 -0.60
Delta at 6 months -0.59 0.75
* P<0.05, compared to baseline
SeleCT Patient Selection Analysis
Who is responsible for paying for the SeleCT report fee?
Olympus has made the decision to provide access to SeleCT at no additional charge, in order to assist in patient selection for bronchoscopic lung volume reduction (BLVR) treatment with SVS and help ensure best possible patient outcomes.
Will there be an offering for SeleCT reports to be done at the 45-day timeframe?
At this time, SeleCT reports are only offered for patient selection/work-up.
What software system is used?
Olympus has it's own proprietary software that has been cleared by the FDA for quantitative characterization of eligibility criteria. Before the results are provided, they are reviewed by a trained specialist.
What is the process for uploading a scan?
Reference SeleCT CT Acquistion Protocol.
Will contrast automatically disqualify a scan for SeleCT?
Reference SeleCT CT Acquistion Protocol.
Is there a value to give to the radiologist for “smooth kernel” reconstruction?
Reference SeleCT CT Acquistion Protocol.
How do I ensure that the scan has been deidentified?
CT scan deidentification depends on the selected service type. Reference the respective SeleCT Quick Reference Guide
What happens if my SeleCT scan is rejected?
Reference SeleCT Quick Reference Guide.
When a scan is rejected it can be re-uploaded for no additional cost. How often can that be done? Is there a limit per physician or institution?
There is no limit per physician or institution to reupload scans.
Who will define “diffuse homogenous emphysema” on the patient's CT?
The radiologist at the institution where the CT scan was performed will read the CT and submit a report. This report generally also includes a characterization of the emphysema pattern.
REACH Clinical Trial
Why is the pneumothorax rate so low? Does the lack of the 9mm valve have anything to do with it?
From the REACH3 publication:
The markedly lower pneumothorax rate in our study may be attributable to a very conservative post-operative care regimen, with patients staying in-hospital for a median of 6 days post-intervention and exposed to limited activities of daily living, which has been previously shown to reduce pneumothorax incidence.

In this study, the average emphysema severity in the ipsilateral lobe was 34.6%, with an emphysema heterogeneity between lobes of 28.4% (see Table 2). In contrast, the ipsilateral lobe emphysema severity in the TRANSFORM and LIBERATE studies was 45.4% and 47.5%, respectively, and this may account for the comparatively lower pneumothorax rate seen in the REACH study. Gompelmann, et al2., have also noted that with greater emphysematous destruction of the untreated ipsilateral lobe there is an increased incidence of pneumothorax.
Alpha-1 Antitrypsin EMPROVE Study
Are the Alpha-1 patient SAE’s captured in the total EMPROVE SAE’s or are they captured separately? If separately what are they (specifically exacerbations and pneumothorax rate)?
The Alpha-1 patients were part of an independent treatment arm, so the SAEs associated with their treatment were reported separately from the EMPROVE main treatment arm. A total of 20 Alpha-1 subjects were treated in EMPROVE. 3/20 (15%) subjects had a serious pneumothorax and 4/20 (20%) had a non-serious pneumothorax. COPD exacerbation rate for the Alpha-1 study arm was 15% (3/20).
Did any of the Alpha-1 patients move on to transplant?
2/20 did. One subject during the 0-6 month phase had double lung transplant; one subject during the 6-12 month phase had a double lung transplant.
Were the Alpha-1 patients Heterozygous or Homozygous?
We did not define this in the protocol, so it was left up to the physician’s discretion. We did not document how many of the Alpha-1 patients were heterozygous vs. homozygous.
Procedure Overview
What data exists on doing a staged procedure for multiple lobes?
The EMPROVE and REACH trials did not include protocols for staged procedures. Therefore, the data does not address whether this may be efficacious.
Is the membrane flammable? Can I use a laser to remove the valves if necessary?
The valve membrane has not been tested for flammability and the use of a laser on or near the valve has not been studied.
What are the criteria that should be used when selecting a primary and secondary target lobe?
EMPROVE used emphysema destruction as the number one factor when determining which lobe to treat. In the event of a tie the perfusion scan was used as a tie breaker.
Were the Alpha-1 patients Heterozygous or Homozygous?
We did not define this in the protocol, so it was left up to the physician’s discretion. We did not document how many of the Alpha-1 patients were heterozygous vs. homozygous.

Dr. Criner at Temple recently presented his order of importance when selecting a target lobe. That list, in order of priority is:

  • Fissure integrity (Collateral ventilation)
  • Emphysema destruction
  • Perfusion
  • Volume
  • Degree of heterogeneity
  • Anatomy
Does the SVS require a 3-night stay post procedure?
In its approval of the SVS, FDA did not mandate a 3-night stay, as they did for the PulmonX Zephyr Valve.
  • REACTIVE ONLY: During the EMPROVE study an overnight stay was required. If the investigator had a high suspicion of potential pneumothorax, they were allowed to keep the patient longer, per their medical discretion. The mean hospital stay in EMPROVE was 3.81 days, with a median of one day.
Reimbursement
How does patient length of stay influence the consideration of whether bronchoscopic lung volume reduction is designated as an inpatient procedure?
Medicare and other payers require the patient stay in the hospital greater than 48 hours (Two-Midnight Rule) to be considered an inpatient stay. Case specific circumstances (e.g. need for monitoring) will assist the physician in determining how long the patient needs to stay in the hospital, and whether the EBV insertion is designated as an inpatient or outpatient hospital procedure. It is important if the physician deems the patient needs to stay in the hospital greater than 48 hours that they document the reason why this clinical decision was made.

Spiration® Reimbursement Helpline
Olympus has designated services and programs available to assist you with all of your reimbursement quefstions and needs related to the Spiration Valve System.

Contact Information:
Hours: 9:00 am – 5:00 pm Eastern Standard Time
Phone: 855-428-7346
Email: SpirationValveReim@olympus.com

Need Basic Reimbursement Information?
Feel free to call or email us and our trained staff can assist you with questions on billing, coding, and reimbursement for the Spiration Valve System.
Looking for More Support?
Experienced coding experts are available to help providers navigate your case-specific denials and prior authorizations. Our experts can assist with communication and paperwork between your payers, and then update you on case-specific decisions through a secured provider portal.

If you are interested, please contact the Spiration Reimbursement Helpline to learn more about this service.

NOTE: A signed Business Associates Agreement is required for this level of service.
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.