A Minimally Invasive Treatment Option for Patients with Severe COPD/Emphysema

With over 25,000 patients treated globally, the Zephyr Valve, FDA approved in 2018, is proven to help improve your patient’s lung function, exercise capacity and quality of life—without traditional surgery and many of its associated risks.²⁰

If you treat patients with severe COPD and emphysema, we’re here to help.

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COPD-Technology-Zephyr-Valve-Referring-Physicians

Initial Patient Selection

Patients who meet the following criteria should be evaluated for treatment with endobronchial valves:^1-5

Breathless despite optimal medical management (mMRC≥2)
A confirmed diagnosis of COPD
Non-smoking or willing to quit smoking
Have an FEV_₁ ≤50% predicted

For more detailed information on clinical data and patient selection criteria please download our free resources.

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GOLD 2020: Level A Evidence rating affirms that endobronchial valves, like the Zephyr Valve, are a viable, minimally invasive treatment option for severe emphysema, a form of COPD.

Indication and Mechanism of Action

Endobronchial Valves are a new category of treatment for COPD and emphysema. The Zephyr Endobronchial Valve was approved by the FDA in 2018 and is indicated for the bronchoscopic treatment of patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation (CV). The Zephyr Valve is an implantable device used to occlude all airways feeding the hyperinflated lobe of a lung that is most diseased with emphysema.

These one-way valves comprised of nitinol and silicone allow trapped air to escape during exhalation, but close to prevent air from re-entering during inhalation. This allows atelectasis of the treated lobe and reduction in target lobe volume. The remaining lobes are then able to expand more fully and work more efficiently, reducing pressure on the diaphragm and improving overall lung function and breathing mechanics.¹

If you’d like to learn more about how the Zephyr Endobronchial Valve
treatment can help your patients, our dedicated specialists are here to help.

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Clinical Evidence

The Zephyr Endobronchial Valve Shows Clinically Significant Benefits in Lung Function, Exercise Capacity, and Quality of Life.

4 randomized clinical trials published using preselection tools to qualify appropriate patients^1-5
Published in the New England Journal of Medicine, The Lancet, and The American Journal of Respiratory and Critical Care Medicine^1-5

Statistically significant and clinically meaningful improvements compared to standard of care in multiple trials^1-4
GOLD 2020: Level A Evidence rating
Treatment success seen in a broad range of primary and secondary endpoints^1-5

RCT	Design	Sample size & follow-up period	Procedural Success (TLVR%)	Difference Zephyr Valve vs. Control Groups (ITT)
RCT	Design	Sample size & follow-up period	Procedural Success (TLVR%)	Lung function (fev₁%) MCID = 10%-15%	Excercise capacity (6mwd) MCID = 26 m	quality of life (sgrq) MCID = -4 pts
LIBERATE¹	2:1 Randomization Heterogeneous only Multicenter	n=190 12 months	84%	18.0% p<0.001	39 m p=0.002	-7.1 pts p=0.004
TRANSFORM²	2:1 Randomization Heterogeneous only Multicenter	n=97 6 months	90%	29.3% p<0.001	79 m p<0.001	-6.5 pts p=0.031
IMPACT³	1:1 Randomization Homogeneous only Multicenter	n=93 6 months*	89%	16.3% p<0.001	28 m p=0.016	-7.5 pts p<0.001
STELVIO^4,5	1:1 Randomization Heterogeneous & Homogeneous Single Center	n=68 6 months	88%	17.8% p=0.001	74 m p<0.001	-14.7 pts** p<0.001

*Data on file at PMX (not in publication)

**Completed cases, all other values listed are ITT population

T Difference between valve and control groups

Pulmonx-Zephyr-Clinical-Study-Summary-Table

If you have a patient with COPD that you would like to have evaluated for treatment with the Zephyr Valve,
we can connect you with a Zephyr Valve trained physician.

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Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.

25,000 People Have Been Treated with the Zephyr Valve

Mahajan-73-year-old-male-Lung-Scan-Spotlight

73-year-old Male Patient

Significant improvement in FEV₁, decrease in TLC and RV, and increase in 6MWD

62-year-old Female Patient

Marked reduction in volume in the treated lung

55-year-old Female Patient

Significant improvement in RV and FEV₁, decrease in TLC, and increase in 6MWD

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United States Brief Statement: The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. The Zephyr Valve is contraindicated for: Patients for whom bronchoscopic procedures are contraindicated; those with evidence of active pulmonary infection; known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium); known allergies to silicone, or with large bullae encompassing greater than 30% of either lung; Patients who have not quit smoking. The Zephyr Valve should be used with caution and only after careful consideration in treating patients with: Prior lung transplant, LVRS, median sternotomy, or lobectomy; Congestive heart failure or recent myocardial infarction; FEV1 <15% of predicted value. Use is restricted to a trained physician. Prior to use, please reference the Zephyr Endobronchial Valve System Instructions for more information on indications, contraindications, warnings, all precautions, and adverse events.

Caution: Federal law restricts this device to sale by or on the order of a physician.

International Brief Statement: The Zephyr® Endobronchial Valve is an implantable bronchial valve intended to control airflow in order to improve lung functions in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks. The Zephyr Valve is contraindicated for: Patients for whom bronchoscopic procedures are contraindicated; Evidence of active pulmonary infection; Patients with known allergies to Nitinol (nickeltitanium) or its constituent metals (nickel or titanium); Patients with known allergies to silicone; Patients who have not quit smoking. Use is restricted to a trained physician. Prior to use, please reference the Zephyr Endobronchial System Instructions for more information on indications, contraindications, warnings, all precautions, and adverse events.