FDA Approves Valve for the Treatment of Emphysema

FDA Approves Valve for the Treatment of Emphysema

Emphysema is a progressive, life-threatening form of chronic obstructive pulmonary disease (COPD) that affects an estimated 3.5 million Americans.

In patients with emphysema, walls between the lungs’ air sacs are damaged, inhibiting oxygen flow. This can cause shortness of breath that makes everyday tasks very difficult.

New Treatment Option for Emphysema

Until recently, treatment for emphysema was limited to invasive surgical options, such as lung transplantation or lung volume reduction surgery.

In June of 2018, the Food and Drug Administration approved a minimally-invasive devise that can be used to treat patients with severe emphysema. The Zephyr® Endobronchial Valve System proved to be effective and less risky than existing treatments.

In fact, the FDA granted Breakthrough Device designation to the valve, meaning the company received intensive guidance to expedite development and review of the valves. The FDA chose to expedite the process in the best interest of emphysema patients who could benefit from the new technology.

The device was analyzed through a multi-center study of 190 patients with severe emphysema. Nearly half the study’s patients treated with Zephyr Valves experienced a 15% improvement in lung function. They reported higher energy levels, an easier time breathing and an improved quality of life.

The valves are about the same size as a pencil eraser. They are strategically placed in a patient’s lungs with the use of a flexible bronchoscope. Their placement protects damaged parts of the lung. The devices then open during exhalation and close during inhalation, helping the lungs to regain normal function lost when air sacs are damaged.

Limitations of the Valve

Although the valve shows great promise, there are limitations to who can receive this breakthrough treatment. A patient won’t qualify if they:

  • Have an active lung infection
  • Are allergic to nickel, titanium, silicone or nitinol
  • Are an active smoker
  • Cannot tolerate bronchoscopic procedures

It may also not be an option for patients with a history of heart disease or major lung procedures.

Though the procedure is minimally invasive, there are still potential risks. A person should speak with their health care provider to determine if the Zephyr Valve is a safe and viable treatment option for them.

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