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3. Eligibility/Criteria Questions

  • On March 1, 2023
  • General Criteria Question: Generally, candidates who should be evaluated for Zephyr Valve Treatment are patients who:
    • Have a confirmed diagnosis of COPD or emphysema
    • Have to stop to catch their breath often, even with taking their medication as directed
    • Have reduced lung function (FEV1≤50% predicted)

These are general criteria but only a Zephyr Valve trained physician can determine if you are a candidate. There is an evaluation process to determine if you are a candidate for the treatment.

{collect email or postal address to send the patient a treatment centre list and referral information}

 

  • What tests do I need to have to see if I qualify for the valves? 

A simple set of tests are required to determine if you might be a good candidate for the treatment. These include pulmonary function testing (PFTs), a CT scan, ABG (a blood test), and the 6-minute walk test. Additional tests may include an echocardiogram and a perfusion scan.  {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • Can I still smoke with this product?

No. Patients will have to quit smoking at least 4 months prior to the procedure and must refrain from smoking after the procedure.

 

  • Do I need to quit smoking?

Yes, you will need to quit smoking at least 4 months prior to receiving the Zephyr Valve Treatment and must refrain from smoking after the procedure.

 

  • Nicotine Patch?

Patients with a nicotine patch are fine to have valves if they qualify.

 

  • Is there an age limit?

The procedure is for adult patients (18 years and older). Their physician will determine if you are a candidate but there is no strict upper age limit. It is up to the treating doctor and is specific to the patient’s work-up/health/comorbidities. {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • Is there a weight or BMI restriction:

While excess body weight is not a contraindication for the procedure, your doctor will make a decision to treat or not to treat based on the determination of whether you can safely undergo the procedure.

 

  • Allergy Question:

The Zephyr Valve is made of nitinol and silicone. Nitinol contains both nickel and titanium.  Therefore, if you have an allergy to Nitinol, nickel, titanium, or silicone, the valves would not be an option for you. {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • Can I have this if I have <some other medical condition>?

 The Zephyr Valve is intended for the treatment of severe COPD/emphysema. Pulmonx is the manufacturer of the Zephyr Valve and we can answer questions about how the valve works but cannot provide any medical advice. There is an evaluation process that will be completed by a Zephyr trained doctor to determine if you are a candidate for the treatment. You should inform the evaluating doctor of all your other medical conditions and past treatments, as they may be a factor in deciding if this treatment option is right for you. {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • What are the benefits of the treatment?

Clinical data showed that at one-year after treatment, patients who received the Zephyr Valve in addition to their usual medication experienced the following benefits compared to patients on medications alone. (1)

Could breathe easier due to improved lung function.

Could do more exercise and walk farther.

Could do more daily life activities, such as walking, bathing, and gardening.

Enjoyed a better quality of life with more energy.

Felt more confident leaving their home.

 {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • Is it safe? 

The Zephyr Valve treatment was approved by the TGA based on an assessment of the safety and effectiveness of the technology observed in the clinical trials. As with any other medical product or procedure, there are associated benefits and risks. Your treating physician has been trained on this procedure and should walk you through all the risks and benefits so you can weigh these benefits and risks for yourself. These risks and benefits are also outlined in the Zephyr Valve patient brochure. {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • What is the recovery time?

Following Zephyr Valve treatment, patients stay in the hospital for 3 nights to allow for careful observation. In most cases, patients are able to go home after 3 nights if there are no complications. Some patients may end up staying longer than 3 nights if they develop a pneumothorax (tear in the lung), a known side effect of this treatment or another complication.  Most patients are able to resume normal activities within a couple of weeks. {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • What is the mortality rate?

In the clinical trial for FDA approval of the Zephyr Valves, in the 45-day period after the procedure, the mortality rate in the Zephyr Valve treated group was 3.1% compared to 0% in the untreated group. Beyond the 45 days out to one year, the mortality rate was 0.8% in the Zephyr Valve treated group compared to 1.6% in the untreated group.

 

  • What are the success rates? 

The clinical trials of the Zephyr Valve procedure show that over 77% of the treated had meaningful improvement in one or more of the outcomes of improved lung function, improved ability to exercise, and improved quality of life. (1) As with any medical product, individual patient outcomes from the use of Zephyr Valves outside of these clinical studies may vary. {collect email or postal address to send the patient a treatment centre list and referral information}

 

  • Can the valves come out?

The Zephyr Valves are designed to be permanent, but they are removable and can be removed or replaced if necessary.

 

Who is the best doctor/Which doctor do you recommend? 

 As a medical device company, we cannot recommend any specific physician.  {collect email or postal address to send the patient a treatment centre list and referral information}

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