FDA Approves Zephyr Valve for Patients with Severe Emphysema

FDA Approves Zephyr Valve for Patients with Severe Emphysema

The U.S. Food and Drug Administration (FDA) has approved Pulmonx’s Zephyr Endobronchial Valve, a device designed to treat patients with severe emphysema who experience difficulty breathing.

Emphysema is a type of chronic obstructive pulmonary disease (COPD) that results from damage to the alveoli, the small air sacs in the lung. Damaged alveoli cause air to become trapped in the lungs, ultimately depriving the body from the oxygen it requires. It is estimated that 3.5 million American adults are diagnosed with emphysema.

Currently, there are very few treatment options for patients 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,” Tina Kiang, PhD, said in a press release. Kiang is acting director in the division of anesthesiology in the FDA’s Center for Devices and Radiological Health.

“This novel device is a less invasive treatment that expands the options available to patients,” Kiang added.

Zephyr valves are small, minimally-invasive valves that are placed in damaged lung airways. Once in place, these valves block damaged regions, allowing healthy lung regions to work more efficiently. During inhalation, Zephyr valves close, which prevents air from entering the damaged part of the lung. During exhalation, the valves open, which helps let out the trapped air, which relieves pressure.

The Zephyr valves are inserted in the patient’s airway through the use of a flexible bronchoscope operated by a doctor in a hospital setting.

The use of Zephyr valves has been linked with improved breathing and improved quality of life for patients.

Prior to approving Zephyr valves, the FDA reviewed clinical data from a multi-center study assessing 190 patients with severe emphysema (NCT01796392).

In total, 128 of 190 patients were treated with Zephyr valves in addition to optimal medical management as designated by current clinical guidelines, which include medications such as bronchodilators, corticosteroids, antibiotics, or anti-inflammatory maintenance medications, as well as pulmonary rehabilitation (a program of exercise, education, and support to help improve lung function).

The remaining 62 patients (the control group) received medical management only.

Results indicated that one year after treatment, almost half (47.7%) of the patients treated with Zephyr valves experienced a 15% (or more) improvement in lung function scores, compared to only 16.8% of patients in the control group.

Taken together, the results suggest that Zephyr valves can offer a significant clinical benefit to patients with severe emphysema.

Of note, the Zephyr valve is not indicated for patients with active lung infections, including those who are allergic to nitinol, nickel, titanium or silicone, active smokers, and those who can’t undergo the bronchoscopic procedure.

Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queen’s University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimer’s disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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Iqra holds a MSc in Cellular and Molecular Medicine from the University of Ottawa in Ottawa, Canada. She also holds a BSc in Life Sciences from Queen’s University in Kingston, Canada. Currently, she is completing a PhD in Laboratory Medicine and Pathobiology from the University of Toronto in Toronto, Canada. Her research has ranged from across various disease areas including Alzheimer’s disease, myelodysplastic syndrome, bleeding disorders and rare pediatric brain tumors.
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6 comments

  1. mavis emery says:

    i have had copd for 20 yrs,i have been on all the inhalers you can think of,but nothing works for me ,i am 80 yrs old .Will it be to late for me to try this thing you are talking about.?

    • Jennie Lee says:

      Hello, Mr. Steve Ross. I live in the Northern, Virginia area, and there was a report on our local Channel 4 (NBC) news at 5pm yesterday. This procedure is now FDA APPROVED in my State.
      I have been on pretty much everything you could imagine for COPD., Asthma, etc. They don’t work for me. I am very much looking forward to talking with my Pulmonologist about this. I have been hospitalized at least 6 times for this issue, that I just developed (or found out about) in less than 3 years. I have 4 inhalers, on a breathing machine, and other meds for this, and by God I am willing to try anything at this point. The women that had the surgery was on the “News Segment”, and had the surgery at Virginia Medical Center, in Arlington, VA, and she could not get within 15 feet from her sitting position to turn a light on or off without feeling as we all feel when it flares up so badly. Steve, I sympathize with you like you are a Brother. I hate having this, and I am only 58, so if I can help it I will consider a non-invasive surgery, such as this one, depending on what my Dr. says, and others that may have had this surgery. I will pray that you also think about it. Please keep in touch if possible as I am curious, and I will contact you, especially if I end up having this surgery. I hope you do the same. All my Best to you & yours Steve. JENNIE

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