Welcome to the Virtual Tour for Interventional Pulmonologists

Breakthrough Technology for Severe Emphysema

Helping Patients Breathe Easier, Do More, and Enjoy Life

The Zephyr® Valve delivers durable clinical benefits — without surgery and its associated risks.1-5

Patients experience:1-5

  • Improved health status
  • Improved lung function
  • Increased exercise capacity
  • Reduced breathlessness or dyspnea
  • Reduced gas trapping
  • Improved quality of life
2020-GOLD-Evidence-A-Zephyr-Valve
20000-Patients-Treated-Globally-Zephyr

Dr. Gerard J. Criner Takes You on Virtual Tour of a Zephyr Procedure

Dr. Criner Patient Case Study

Patient Information:

  • 77-year-old female
  • BMI 27
  • FEV1 29% predicted
  • TLC 156% predicted
  • RV 228% predicted

StratX®

Prior to treatment, physicians perform a clinical workup, including lung function and hyperinflation testing. The StratX Lung Analysis Platform is a cloud-based quantitative CT analysis service that provides information on emphysema destruction, fissure completeness, and lobar volumes.

The StratX Lung Report is used in treatment planning to select primary, secondary, and tertiary target lobes for treatment. Dr. Criner used this StratX Lung Report to select this patient’s target lobe, verify fissure integrity and ultimately place 5 valves as seen in the below videos. This StratX report displays the left lower lobe as the most destructed (60%), with a high fissure completeness (100%) and high inspiratory volume (1,295).

Patient-StratX-Criner

Chartis® Assesses Collateral Ventilation

The Chartis System has been validated in multiple randomized clinical trials1-4 to predict likely responders to the Zephyr Valve treatment. Chartis provides precise flow and pressure readings for specific lobes in the lung to assess absence of collateral ventilation (CV), which is a predictor of response to treatment.

In this video Dr. Criner demonstrates how Chartis is used to assess the presence of CV within isolated lobes of the lung.

Patient Overview:

  • 77-year-old female
  • BMI 27
  • FEV1 29% predicted
  • TLC 156% predicted
  • RV 228% predicted
  • 5 valves placed in the left lower lobe

Zephyr Valve Placement

Dr. Criner demonstrates placing 5 Zephyr Valves in the Left Lower Lobe

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

Post Procedure Patient Outcomes

Chest CT Pre-Zephyr Procedure

Case-study-pre-CXR

Baseline shows lower lobe predominant emphysema, hyperinflation and flattening of the diaphragm.

Chest CT Post-Zephyr Procedure

Case-study-post-CXR

Post scan shows atelectasis of the left lower lobe and lifting of the diaphragm.

Clinical Evidence

  • 4 RCTs published using Zephyr Valve and Chartis to preselect patients1-5
  • Published in the New England Journal of Medicine, The Lancet, and The American Journal of Respiratory and Critical Care Medicine1-5,16
  • Statistically significant and clinically meaningful improvements compared to standard of care in multiple trials1-4
  • Treatment success seen in a broad range of primary and secondary endpoints1-5

Consistent Clinical Findings Across Four Randomized Controlled Trials

RCTDesignSample size & follow-up periodProcedural Success (TLVR%)Difference Zephyr Valve vs. Control Groups (ITT)
Lung
function
(fev1%)
MCID = 10%-15%
Excercise capacity
(6mwd)
MCID = 26 m
quality
of life
(sgrq)
MCID = -4 pts
LIBERATE12:1 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
TRANSFORM22:1 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
IMPACT31:1 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
STELVIO4,51:1 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
*Completed cases, all other values listed are ITT population

Responder Rates for Zephyr Valve and Spiration Valve

Responder Rates for Endobronchial Valves for Bronchoscopic Lung Volume Reduction*1-4,35,36

Randomized Trials of CV- Patients**

Responder-Rates-2

The committee noted that there are different devices available for this procedure, and that the published evidence shows they may have different efficacy profiles.”
— NICE 201711

*Comparisons based on retrospective review of data, no head-to-head trials have been conducted.
**Collateral ventilation status determined by fissure integrity (QCT) or physiologic measure (Chartis) of CV.

Responder Rates and Incidence of Significant Pneumothorax

Pneumothorax-Events-Safety-Data
**Significant pneumothorax defined as a tension pneumo or a pneumo that requires >7 days hospitalization, surgery, all valve removal, or results in death

Pulmonologist Perspective: 
How Zephyr Valves Work

Physician-Testimonial-2

Assess with Certainty. Treat with Confidence.

Used together, StratX and Chartis predicted successful TLVR with 90% accuracy.6

Patients without collateral ventilation (CV-) are more likely to respond to treatment with endobronchial valves. Pulmonx offers precise patient selection tools to help physicians identify those most likely to benefit from treatment.

StratX Platform

QCT Analysis:
Non-invasive to rule out non-responders

Perfect-teaching-StratX-Rev-Transparent

Chartis Pulmonary Assessment System

Physiological assessment for collateral ventilation to identify likely responders

Chartis-Pulmonx-Patient-Selection

Using QCT alone may exclude patients with no collateral ventilation from being treated or treat patients with collateral ventilation who may receive no benefit.

Used prior to placement of valves, StratX and Chartis give physicians confidence in their treatment decision and are a critical addition to analysis of fissure completeness. Without Chartis, physicians may treat a lobe that has collateral ventilation, or unnecessarily rule out a patient who could have benefitted.

Patient Selection Benefit Of Chartis7

Chartis-Collateral-Ventilation-Confidence
*Includes patients with “low plateau” measurements, typically not achieving TLVR when treated
**Includes patients with “low flow” readings in the target lobe, typically resulting in TLVR when treated

Featured Patient Stories

How-Zephyr-Valve-Works-COPD-Emphysema

How It Works

See how the Zephyr Valve treatment is performed as a minimally invasive lung volume reduction procedure to reduce hyperinflation and gas trapping in patients with severe emphysema. The Zephyr Valve is the first endobronchial valve to receive approval from the FDA for patients with either heterogenous or homogeneous emphysema.

Comprehensive Solutions to Support
You and Your Patients

Pulmonx is committed to serving hospitals, physicians, and patients across the continuum of care to help you deliver superior patient outcomes.

Education-Case-Support

Professional Education & Case Support

Pulmonx delivers high quality professional education for physicians and their teams to help them achieve superior patient outcomes and patient satisfaction.

  • Off-site dedicated training sessions with the field’s leading experts for treating physicians and their teams
  • On-demand comprehensive training module
    available online
  • Patient selection case study training modules
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Patient Access & Reimbursement Support

Pulmonx provides dedicated support to healthcare providers and associated facilities, patients, and their families as they navigate through the reimbursement process.

  • Supporting patients and providers as they navigate coverage with a dedicated team of experienced
    case managers
  • Collaborating with your administrative and coding and billing teams to ensure appropriate understanding of reimbursement situation
  • Educating payers and monitoring insurance coverage developments impacting patient access
Research-And-Development

Research & Development

Our team is developing leading edge tools to deliver superior patient outcomes.

  • Gaining insights from physicians and through evidence-based medicine to enhance products and assessment tools
  • Investing in long-term clinical research with meaningful primary and secondary endpoints
Patient-Awareness-Market-Development

Patient Awareness & Market Development Support

Many patients living with emphysema don’t know that they have options. Pulmonx is dedicated to increasing awareness of this treatment.

  • Engagement with patients and patient advocates
  • Promotion of a patient-centered website with a Zephyr Treatment Center locator
  • Partner and sponsor of events for patient awareness
  • Educational resources that treating facilities and professionals may use for community outreach
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