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FDA approves Zephyr Valve for severe emphysema



The FDA has today approved the Zephyr Endobronchial Flap for the treatment of respiratory problems associated with severe emphysema, according to a press release.

"Treatment options are limited for people with emphysema whose symptoms have not improved by taking medication, including lung operations such as lung volume reduction or lung transplantation, which may not be suitable or appropriate for all patients." Tina Kiang , PhD, Deputy Director of the Department of Anaesthesiology, General Hospital, Respiratory, Infection Control and Dental Equipment in the FDA Center for Equipment and Radiological Health, said in the release. "This novel device is a less invasive treatment that extends the possibilities for patients."

The small device is implanted by a flexible bronchoscope in the diseased areas of the lung airways, according to the FDA. The Zephyr Valve (Pulmonx) prevents air from entering the damaged parts of the lungs and, according to the FDA, releases air and fluids.

FDA approval is based on results from a study of 1

90 patients with severe pulmonary emphysema.

  African-American man talking to the doctor at the hospital

The FDA approved the Zephyr endobronchial valve for the treatment of severe respiratory problems in severe emphysema

Photo credit: Adobe Stock

Participants were assigned to the intervention group and control group. Patients in the intervention group received treatment with zephyr valves, pulmonary rehabilitation and medical treatment with drugs such as bronchodilators, corticosteroids, antibiotics or anti-inflammatory drugs that met current clinical guidelines (n = 128). Those in the control group received only one medical treatment (n = 62).

The study found that lung function values ​​were improved by at least 15% after 1 year in almost half of participants (47.7%) treated with zephyr valves 16.8% of patients in the control group

Side effects, including death, pneumothorax, pneumonia, worsening of emphysema, hemoptysis, shortness of breath and chest pain have been reported by the FDA.

The FDA noted the zephyr valve is contraindicated in patients with active lung infections, active smokers, patients who can not tolerate the bronchoscopic procedure, and those who are allergic to nitinol, nickel, titanium or silicone

patients If you have severe pulmonary surgery, heart disease or major problems, air bubbles trapped in the lungs or unresponsive to other treatments should be discussed with your healthcare provider to determine if the Zephyr valve device is suitable for you.

"Zephyr valves are a major step in treating patients with severe emphysema who feel constantly out of breath despite all the medicines we can offer." Gerard Criner, MD, Chairman and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University said in a separate Pulmonx press release. "I have seen how patients treated with Zephyr valves return to a more active life by doing the things they enjoy, and as a doctor, it is gratifying to have a new treatment that restores patient confidence and their lives

Disclosure:

Healio Internal Medicine failed to validate the relevant financial information at the time of publication.


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