About The Zephyr Valve System
What is the Zephyr® Valve?
The Zephyr® Valve is thefirst FDA-approved, minimally-invasive device available in the U.S. for treating patients with severe emphysema.
Who is the Zephyr® Valve for?
The Zephyr® Valve is for severe emphysema patients who consistently feel short of breath despite using COPD medications and/or oxygen.
What are the benefits of Zephyr® Valves?
Patients report being able to take full breaths immediately after the procedure and within a few days are back to doing everyday tasks with ease. In clinical studies patients treated with Zephyr® Valves have been shown to:
- Be more active and energetic
- Be less short of breath
- Enjoy a significantly improved quality of life compared to untreated patients
How do Zephyr® Valves work?
If you have COPD/emphysema you may struggle to catch your breath while doing everyday tasks. This is because the damaged parts of your lungs have lost their ability to release trapped air and have become overinflated. Zephyr Valves are tiny, one-way valves that allow the trapped air to be exhaled from the lungs and prevent more air from becoming trapped there. This helps you to breathe better and do more.
Zephyr Valve Procedure Pros
The Zephyr Valve procedure is designed to offer several benefits. Its intended to deflate an area of the lung with airflow issues, which can help improve the function of the rest of the lung. Also, this procedure is designed to help improve your ability to exercise, and it may lead to a significant improvement in your quality of life.
Are Zephyr Valves Permanent
The lung volume of the treated lobe is reduced when the air escapes through the Zephyr Valves. Valve is designed to be a permanent fix for this problem. In the case of a lung transplant, the lungs are removed from the donor and placed into the recipients body. However, in some cases, it may be necessary to do so.
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How Long Does It Take To Recover From Zephyr Valve Surgery
If you have a tear in the lung tissue you can go home after 3 to 5 days.
If this happens, your doctor may put a small tube in your chest to let out the air from the tear, and you may need to stay in the hospital up to a week or more.
If you are allergic to any of the ingredients in this product, stop using it and consult a doctor right away.
Lung Changes In Emphysema
Emphysema is progressive and characterized by destruction of alveolar walls distal to the terminal bronchioles, resulting in permanent enlargement of airspaces. Loss of connective tissue corresponds to loss of elastic lung recoil and reduced tethering of the small airways with consequent air trapping, hyperinflation, and collapse of small airways.
Hyperinflation increases the work of breathing by pushing the tidal volume loop to the less compliant portion of the respiratory volume-pressure curve, so that patients must generate more pressure to breathe in or out .
Pressure-volume loops while breathing at rest and during exercise in a healthy individual and in a patient with chronic obstructive pulmonary disease . Inspiratory capacity increases in healthy people during exercise owing to a fall in lung volume at the end of exhalation. The volume loop during normal breathing is situated in the central linear portion of the pressure-volume relationship, which means that relatively small changes in pressure produce comparatively large changes in volume. In COPD, inspiratory capacity declines due to progressive air-trapping during exercise thus, patients have to breathe at the upper and less compliant portion of the pressure-volume relationship. This means that increasingly higher pressures must be generated for any given breath, increasing the work of breathing.
Used with the permission of the American Thoracic Society.
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Thoracoscopic Bullectomy Using A Trans
An UpToDate review on definitive treatment and prevention of pneumothorax recommended video-assisted thoracoscopic surgery apical blebectomy/bullectomy simultaneously with pleurodesis based upon retrospective data that report recurrence rates < 5 percent using this combined approach. The authors noted, however, that data are conflicting and some surgeons perform pleurodesis alone based upon data that report lower recurrence rates in patients with VATS-directed insufflation of talc compared with bullectomy alone , while others perform blebectomy/bullectomy alone based upon data that report recurrence rates < 9 percent with bullectomy alone.
The authors stated that the drawbacks of this study were the small number of patients and the single-arm design of the trial. However, this was the first study to prospectively examine the efficacy of thoracoscopic trans-areolar pulmonary bullectomy. In the future, these investigators will carry out a prospective study to compare the trans-areolar and uni-portal approaches.
Further Lessons From Vent
Post hoc analyses from VENT laid the groundwork for trials that delineated the role of endobronchial valve implantation in the treatment of emphysema.
First, improvement in lung function and 6-minute walk distance correlated with the heterogeneity of emphysema: ie, the higher the difference of emphysematous involvement between the treated lobe and neighboring lobes, the more robust the clinical improvement.
Second, the presence of complete fissures between the lobes was associated with greater reductions in lung volume and improvement in lung function. This finding emphasized the importance of absence of collateral ventilation in determining success of the procedure. In essence, despite endobronchial occlusion, the treated lobe could back-fill from the neighboring lobes through collateral ventilation, thereby abrogating lung volume reduction. Absence of any interruption in the pleural lining between the lobes was a surrogate for the absence of collateral ventilation.
Third, complete lobar occlusion was necessary for optimal results. In the VENT study, 44% of the patients had incomplete occlusion of the treated lobe, which likely lessened the benefits from the procedure.
Fissure integrity can be assessed visually or by software analysis on high-resolution CT . Collateral ventilation can be directly investigated with diagnostic tools that can measure pressure and flow within the lung.
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How Long Does Zephyr Valve Surgery Take
You will be given medicine by the doctor to make you sleepy. A small tube with a camera, called a bronchoscope, will be inserted into your lungs through your nose or mouth. Your doctor will place between three and five pens in your airway during the 30- to 60-minute procedure.
The pens will help the doctor see whats going on inside your body. After the procedure, youll need to stay in the hospital for a few days to recover. Youll be able to go home the same day.
Fda Clears Zephyr Endobronchial Valve To Treat Severe Emphysema
Megan Brooks
The US Food and Drug Administration has approved the Zephyr Endobronchial Valve to treat breathing difficulty associated with severe emphysema.
“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients. This novel device is a less invasive treatment that expands the options available to patients,” Tina Kiang, PhD, acting director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA’s Center for Devices and Radiological Health, said in a news release.
The Zephyr valve is the first minimally invasive device approved in the United States for the treatment of patients with severe emphysema, the company noted in a news release.
During a bronchoscopic procedure, Zephyr valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation, allowing the healthier parts of the lungs to take in more air and work more effectively, the company explained. The valves are designed to be permanent but can be removed if necessary.
In the study, 128 patients were treated with Zephyr valves, guideline-based medical management , and pulmonary rehabilitation 62 patients received medical management only.
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Zephyr Valve Procedure Cons
As with any surgery, this procedure also comes with some risks. One risk associated with Zephyr Valve procedures is that they can cause a temporary worsening of emphysema symptoms after surgery.
Some patients may also develop pneumonia or increased mucus production and wheezing after the procedure. Most seriously of all, patients who have Zephyr Valve surgery are at higher risk of developing an air leak in the lung that causes it to collapse within 3 days of having the procedure
Lung Institute DOES NOT offer Zephyr Valve Procedure. The above content is for educational purposes only.
Pulmonx Announces That Humana Has Issued A Positive Coverage Policy For The Zephyr Valve A Less Invasive Treatment Option For Severe Emphysema
Humana® is the second major insurer to post a coverage policy for Pulmonxs Zephyr Endobronchial Valve Treatment
REDWOOD CITY, Calif.—- Pulmonx Corporation, a leader in diagnostic and therapeutic pulmonary device technologies, announced today that its Zephyr® Valve has received positive coverage from Humana® under its new endobronchial valve coverage policy. Humana, a national health insurer in the United States covers more than 10 million members. This decision, together with an earlier positive coverage decision by Aetna®, means that the Zephyr Valve is now an available treatment option for over 30 million Americans with commercial insurance. The Zephyr Valve is a less invasive treatment option for severe emphysema that has been shown to deliver life-changing benefits to COPD patients without the risk of major surgery. Clinical benefits include improved quality of life, less shortness of breath, and the ability to be more active.1
This press release features multimedia. View the full release here:
Zephyr Endobronchial Valve
Under its new coverage policy, Humana specifically names the Zephyr Valve being covered for qualifying patients. The Zephyr Valves are placed in a single bronchoscopic procedure with no incision. The procedure carries much less risk than surgical options including lung volume reduction surgery and lung transplantation.
HUMANA coverage policy:
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The Vent Trial Of Valve Therapy
The Endobronchial Valve for Emphysema Palliation Trial was the first multicenter randomized controlled trial to assess the efficacy and safety of lung volume reduction with Zephyr endobronchial valves. The trial had 2 cohorts, 1 in the United States and 1 in Europe.
In the US cohort, 321 patients with severe and very severe heterogeneous emphysema were randomized in a 2:1 fashion to undergo valve placement or medical treatment . Compared with medical therapy, the valve group had a modest 6.8% between-group difference in FEV1 and a 5.8% difference in 6-minute walk distance. Although statistically significant, these improvements were not considered as reaching a minimal clinically important difference. Adverse events, including pneumothorax, were more common in the valve therapy group . Similar results were obtained in the European cohort.
Given the modest benefit and substantial risk of adverse events, the US Food and Drug Administration recommended against approval of the Zephyr endobronchial valve based on the results of VENT.
Zephyr Valve Treatment For Copd And Emphysema
For patients with severe COPD or emphysema, a new treatment option known as the Zephyr® Endobrachial Valve System has proved successful in improving lung function, exercise capacity and quality of life.
During this minimally invasive procedure, a doctor uses a bronchoscope , to place tiny valves in the airways of the lungs. These valves allow healthy portions of the lungs to expand, lifting pressure off the diaphragm to enhance breathing.
Below are some questions and answers about the Zephyr® Valve.
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Is The Zephyr Valve Fda Approved
FDA approves novel device for treating breathing difficulty from severe emphysema. The U.S. Food and Drug Administration today approved a new device, the Zephyr Endobronchial Valve , intended to improve the quality of life for patients with severe, chronic obstructive pulmonary disease who are unable to breathe on their own.
This device is the first of its kind in the world, and we are thrilled that it has been approved by the FDA for the treatment of severe COPD patients, said Dr. Michael J. Osterholm, M.D., director of the Division of Pulmonary and Critical Care Medicine at the University of California, San Francisco .
It is an important step forward in our efforts to find a cure for this devastating disease, which is estimated to affect more than 1.5 million Americans. We look forward to continuing to work with our colleagues at UCSF and other institutions to develop and test new therapies for these patients and to bring them to market as quickly as possible.
The device consists of a thin, flexible tube that is inserted into the airway through a small incision on the chest.
Pros And Cons Of The Zephyr Valve Procedure
Lung Institute DOES NOT offer Zephyr Valve Procedure. The below content is for educational purposes only.
Recently, the Food and Drug Administration approved a new treatment for emphysema patients called the Zephyr Valve procedure.
We have been following the development and certification of this treatment and want to help you understand what this device is, who its intended to treat, and some pros and cons of this procedure.
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Use Of Polyglycolic Acid Patch In The Treatment Of Pneumothorax By Thoracoscopic Bullectomy
The authors stated that this study had several drawbacks. First, there are only 1,095 patients included in the literature, and most of them were retrospective research, among which only 3 RCTs affected the value of meta-analysis conclusions. Second, the main research subjects included in the literature were mainly Chinese and Japanese, which may have resulted in some selection bias. Third, in calculating pneumothorax recurrence, the studies varied greatly in the follow-up time reported, which may indirectly lead to deviation in the final number, which may also affect the results. Finally, these researchers were unable to compare important data such as intra-operative bleeding volume, and post-operative complications because they were not reported in the relevant literature.
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The Need For Nonsurgical Options
Lung volume reduction surgery has several limitations. It is associated with considerable rates of mortality and morbidity . A study performed between 2007 and 2013 showed that the in-hospital mortality rate was 5.5% and that 5.5% of patients required tracheostomy.
While suboptimal patient selection may also have played a role in poor outcomes in this report , alternative nonsurgical approaches to lung volume reduction are desirable.
Over the past 3 decades, several nonsurgical methods have been devised .- Among these, endobronchial valve implantation is considered the most promising and is currently the only approved bronchoscopic lung volume reduction procedure in the United States.
Valve therapy for bronchoscopic lung volume reduction involves implantation of 1-way valves to allow air flow and mucus clearance outward to central airways. The 1-way flow leads to selective de-aeration and collapse of treated areas, reducing hyperinflation and air trapping. Unlike lung volume reduction surgery, the procedure is performed unilaterally due to the inherent procedural risk of pneumothorax.
There are currently 2 valve therapy options approved in the United States: the Zephyr valve system and the Spiration valve system .
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What Is The New Surgery For Copd
One of the newest treatment options for severe emphysema is a minimally invasive procedure called bronchoscopic lung volume reduction using endobronchial valves. These tiny devices are implanted in the lungs and act as a small airway to reduce the amount of air that gets in and out of your lungs. The procedure can be done in a hospital or outpatient setting, but it is most commonly done at home.
The procedure is usually done under local anesthetic and takes about an hour. After the procedure, you will need to stay in bed for a few days to allow your body to adjust to the new volume. You will be able to return to your normal activities as soon as the volume is back to normal.
Clinical Trials Of Valve Therapy After The Vent Study
There were 7 randomized controlled trials of the clinical efficacy of valve therapy with designs that considered the experience from the VENT study .- Five of these trials used the Zephyr system,- and 2 used the Spiration system., All assessed collateral ventilation during bronchoscopy using fissure analysis, the Chartis system, or both. All but 1 trial enrolled patients with heterogeneous emphysema in whom the treated lobe had 10% to 15% more destruction from emphysema than the neighboring lobes, based on quantitative CT analysis. One trial enrolled both heterogeneous and homogeneous emphysema patients.
Randomized controlled trials of bronchoscopic lung volume reduction
These trials utilized clinical responder analysis as efficacy end points, defined as the proportion of patients who exhibited improvements over the minimal clinically important differenceie, the smallest measured difference that the patient would deem significant, representing the value patients placed on the change. Several thresholds were used in these trials.-
These 7 trials recruited patients with severe to very severe COPD and severe hyperinflation .- Compared with baseline values, patients who received valve therapy experienced lung volume reduction , improvement in lung function , exertional capacity and quality-of-life scores .
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Leader In New Treatment For Severe Emphysema
At the Temple Lung Center, we’re renowned for our experienced medical staff, superior outcomes and leading-edge research. We help people with serious lung disease breathe easier and live more active lives.
Temple is a world leader in the testing and use of endobronchial valves for bronchoscopic lung volume reduction in patients with severe emphysema. In fact, were the first center in the nation to perform BLVR.
Our doctors led both major international studies that proved the valves work the EMPROVE study for the Spiration® Valve System and the LIBERATE study for the Zephyr® Endobronchial Valve. The studies led to both valves being FDA approved. Were also a national training site for pulmonologists who come from across the country including Connecticut, Ohio, Michigan and Arizona to learn how to implant the valves.
Temple Lung Center Director Dr. Gerard Criner has been involved in every major BLVR study over the past 25 years. He led the medical teams that carried out both the EMPROVE and LIBERATE clinical trials that resulted in FDA approval of the Spiration® and Zephyr® valves. He was also the first in the country to implant both valves after FDA approval.
Dr. Criners skills and knowledge as a clinician, researcher and teacher have given options to hundreds of patients who have not responded to other emphysema treatments.
