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FDA Today Approved Zephyr Endobronchial Valve for the Treatment of Respiratory Disorders Associated with Severe Emphysema, According to a Press Release
"Therapeutic options are limited in people with dementia. Emphysema with severe symptoms.These include pulmonary surgery, such as lung volume reduction or lung transplantation, which may not be suitable for all patients. " Tina Kiang, PhD, Acting Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices in the Center for Devices and Radiological Health of the FDA, said in the statement. "This new device is a less invasive treatment that expands the options available to patients."
The small device is placed in the diseased areas of the pulmonary airways with a flexible bronchoscope, according to the FDA. The Zephyr (Pulmonx) valve prevents air from entering the damaged parts of the lung and allows air and trapped fluids to escape, according to the FDA.
The FDA approval is based on 190 patients with severe emphysema.
The FDA today approved the Zephyr endobronchial valve to treat breathing difficulties associated with severe emphysema.
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intervention group and control group. Patients in the intervention group received treatment with Zephyr valves, pulmonary rehabilitation and medical management with drugs such as bronchodilators, corticosteroids, antibiotics or anti-inflammatories consistent with current clinical recommendations. (n = 128). Subjects in the control group received only medical management (n = 62).
The study found that at one year, lung function scores were improved by at least 15% in almost half of the participants (47.7%) 16.8% patients in the control group.
Adverse events, including death, pneumothorax, pneumonia, worsening of emphysema, coughing up of blood, shortness of breath and chest pain have been observed, according to the FDA. that the Zephyr Valve is contraindicated in patients with active pulmonary infections, active smokers, non-bronchoscopic users, and those who are allergic to nitinol, nickel, titanium, or silicone.
Air bubbles trapped in the lungs or that have not responded to other treatments should discuss with their suppliers to determine if the Zephyr valve device is appropriate for them.
"Zephyr valves are a major step in the treatment of patients with severe emphysema who are constantly panting despite all the medications we can offer." Gerard Criner, MD, President and Professor of Thoracic Medicine and Surgery at the University of Lewis Katz School of Medicine at Temple University, said in a separate press release issued by Pulmonx. "I have seen patients treated with Zephyr valve resume a more active life by doing the things that they enjoy.As a doctor, it is very rewarding to have a new treatment that can restore the patient's confidence and change his or her life in the long run. "[19659013] Disclosure:
Healio Internal Medicine was unable to confirm the relevant financial disclosures at the time of publication.
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