Skip to content

Patient Screening Criteria

Zephyr® Endobronchial Valve

A proven treatment for breathlessness from severe COPD/emphysema

The Zephyr Endobronchial Valve is a clinically-proven bronchoscopic treatment for patients with severe COPD/emphysema who suffer from shortness of breath despite optimized medical therapy.

Appropriate patient selection is critical to the success of Zephyr Valve treatment. Over time, clinical trial data have helped define the successful patient profile.1-4,6,7 The Zephyr Valve is the first endobronchial valve to receive approval from the FDA for patients with either heterogeneous or homogeneous emphysema and can be used to treat the upper and lower lobes of either lung.

Patient Eligibility for Zephyr Valve Treatment

If shortness of breath is not controlled with medical management, patients may qualify for Zephyr Valve Treatment.

Medical History

  • Full medical treatment for COPD
  • With or without supplemental oxygen
  • Stable or unstable
  • Persistent COPD symptoms

Clinical Presentation

  • Severe COPD/emphysema
  • Shortness of breath upon activity or rest
  • Limited in daily functions
  • Dissatisfied with activity level and quality of life
ZephyrValve-PurpleCircles
GOLD-Seal-2023

Patient Screening Criteria

Zephyr® Endobronchial Valve

A proven treatment for breathlessness from severe COPD/emphysema

The Zephyr Endobronchial Valve is a clinically-proven bronchoscopic treatment for patients with severe COPD/emphysema who suffer from shortness of breath despite optimized medical therapy.

Appropriate patient selection is critical to the success of Zephyr Valve treatment. Over time, clinical trial data have helped define the successful patient profile.1-4,6,7 The Zephyr Valve is the first endobronchial valve to receive approval from the FDA for patients with either heterogeneous or homogeneous emphysema and can be used to treat the upper and lower lobes of either lung. 

Patient Eligibility for Zephyr Valve Treatment

If shortness of breath is not controlled with medical management, patients may qualify for Zephyr Valve Treatment.

GOLD-Seal-2023
ZephyrValve-PurpleCircles

Clinical Presentation

  • Severe COPD/emphysema
  • Shortness of breath upon activity or rest
  • Limited in daily functions
  • Dissatisfied with activity level and quality of life

Medical History

  • Full medical treatment for COPD
  • With or without supplemental oxygen
  • Stable or unstable
  • Persistent COPD symptoms

Diagnostic Checklist for Zephyr Valve Treatment Eligibility

Diagnosis 

Severe COPD/emphysema

Shortness of breath upon activity or rest

Spirometry 

FEV1 < 50%

6 Minute Walk Test

100-500m / 328-1640 ft
Walk for distance on baseline O2 without O2 titration

Smoking Status

Non-smoking or willing to quit smoking

Diagnostic Checklist for Zephyr Valve Treatment Eligibility

Diagnosis 

Severe COPD/emphysema

Shortness of breath upon activity or rest

Spirometry 

FEV1 < 50%

6 Minute Walk Test

100-500m / 328-1640 ft
Walk for distance on baseline O2 without O2 titration

Smoking Status

Non-smoking or willing to quit smoking

  Common Disqualifying Conditions

  • Prior lung transplant, LVRS, median sternotomy, or lobectomy
  • Congestive heart failure: Left Ventricular Ejection Fraction <45%; unstable cardiac arrythmia, myocardial infarction, or stroke
  • Uncontrolled pulmonary hypertension
  • Known allergies to nitinol, nickel, titanium, or silicone

Download additional criteria.

Zephyr Valve Treatment: Position in Care Pathway38

Zephyr Valve Treatment Position in Care Pathway-Resize

Zephyr Valves can be placed bronchoscopically without many of the risks associated with major surgery, so patients are often evaluated for this treatment before surgery is considered.1

Which patients are candidates for Zephyr Valves?

Patients with varying levels of symptom burdens can benefit from Zephyr Valve Treatment.

Spectrum of qualifying
symptom burden
Shortness of BreathOn activityOn activity & at restContinuous
Activity LevelLimiting activitiesDifficulty with ADLRequires help for
personal care
Oxygen TherapyNonePRNConstant
Exacerbation HistoryNonePast ED visit(s)Past hospitalization(s)

Which patients are candidates for Zephyr Valves?

Patients with varying levels of symptom burdens can benefit from Zephyr Valve Treatment.

Patient Profile Chart

Diagnostic Workup at Treating Center

The clinical team at the Zephyr Valve treating center will confirm patient eligibility with these tests:

  • Full Pulmonary Function Testing using Body Plethysmography
  • 6 Minute Walk Test
  • High Resolution CT Scan with specialized protocols
  • Echocardiogram
  • Arterial Blood Gas (optional)
  • Perfusion Testing (optional)

While all these tests are typically performed at the hospital-based Treating Center, it is sometimes possible to perform some of these diagnostic tests locally. Please confirm protocols with Treating Center personnel before ordering any tests.

US-EN-1834-v1