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The United States Food and Drug Administration (FDA) has approved the Zephyr Endobronchial Valve (Pulmonx Corp) for treating respiratory difficulty associated with severe emphysema.
"Treatment options are limited for people with emphysema. have severe symptoms that have not improved after taking medication, including lung surgery, such as lung volume reduction or lung transplantation, which may not be suitable for all patients, less invasive treatment that broadens Options Available Tina Kiang, Ph.D., Acting Director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA's Center for Radiological Health and Devices, said in a statement. Press release.
The Zephyr valve is the first minimally invasive device approved in the United States for the treatment of patients with severe emphysema, noted the company in a press release.
During a bronchoscopic procedure, Zephyr valves are placed in the airways to occlude a sick part of the lungs and reduce hyperinflation, allowing the healthier parts of the lungs to take more blood. air and work more efficiently, explained the company. The valves are designed to be permanent but can be removed if necessary.
The safety and effectiveness of the Zephyr valve were evaluated in the LIBERATE study, a multicenter randomized controlled trial including 190 patients with severe emphysema for whom there was little to no ventilation. collateral in the target lobe of the lung.
In the study, 128 patients were treated with Zephyr valves, a medical treatment based on recommendations (bronchodilators, corticosteroids, antibiotics or anti-inflammatories) and pulmonary rehabilitation; 62 patients (control group) received medical management only
At 1 year, significantly more patients treated with Zephyr valves experienced at least 15% improvement in forced expiratory volume in 1 second, the main criterion (47.7% vs 16.8%, P <0.001).
Patients treated with Zephyr valves also experienced a statistically significant reduction in the rate of respiratory failure. In addition, there was a trend toward a reduction in hospitalization for chronic obstructive pulmonary disease (COPD) compared with patients receiving medical management alone.
Pneumothorax, most commonly associated with Zephyr, was one of the patients. No intervention was required in approximately 20% of incidents; the majority of other cases have been treated with standard medical management. Other less common side effects include exacerbation of COPD, pneumonia, respiratory failure and death.
The results of the LIBERATE study were published May 22 in the American Journal of Respiratory and Critical Care Medicine . coincides with the presentation at the 2018 International Conference of the American Thoracic Society.
"Zephyr valves are a major breakthrough in the treatment of patients with severe emphysema who suffer from shortness of breath despite all the drugs we can offer," Gerard Criner. , MD, president and professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, said in the news release.
"I've seen Zephyr Valve-patients return to a more active life As a doctor, it's very rewarding to have a new treatment that can restore the patient's confidence and change his life for a long time term, "said Criner.
The Zephyr valve is contraindicated in patients with active pulmonary infections; those who are allergic to nitinol, nickel, titanium or silicone; active smokers;
The Zephyr valve has received the breakthrough device designation and has been approved by a pre-market approval application, which is the most demanding type of device marketing application. and is generally required for high-risk devices.
Since 2007, more than 14,000 patients have been treated with the Zephyr valve worldwide, the company said. For more info, join us on Facebook and Twitter
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