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FDA clears endobronchial valve Zephyr to treat heavy emphysema



The US Food and Drug Administration (FDA) has approved the Zephyr Endobronchial Valve (Pulmonx Corp.) for the treatment of severe respiratory problems in severe emphysema.

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

The Zephyr valve is the first minimally invasive device approved in the United States for the treatment of patients with severe emphysema, the company noted in a press release

during a bronchoscopic examination of English: bio-pro. English:. Zephyr valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation, so that the healthier parts of the lungs get more air and work more effectively, the company said. The valves are designed to be durable, but can be removed if necessary.

The safety and efficacy of the Zephyr valve was examined in the LIBERATE study, a multicentre randomized controlled trial involving 1

90 patients with severe emphysema, for whom there was little collateral ventilation in the target lungs

In the study 128 patients treated with zephyr valves, guideline-based medical management (bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance medications) and pulmonary rehabilitation; 62 patients (the control group) received only one medical treatment

After 1 year, significantly more patients treated with zephyr valves achieved an improvement in forced expiratory volume of at least 15% within 1 second (47.7% vs. 16, 8% P <.001).

There was also a statistically significant reduction in the rate of respiratory failure in patients treated with zephyr valves. In addition, there was a trend toward a reduction in hospitalization for chronic obstructive pulmonary disease (COPD) compared to patients receiving medical treatment alone.

The most common side effect of zephyr valve treatment was pneumothorax, which occurred in about one-third of patients. In about 20% of cases, no intervention was required; The majority of the remaining cases were treated with standardized medical management. Other side effects that were less common were COPD exacerbation, pneumonia, respiratory failure, and death.

The results of the LIBERATE study were published on May 22 in the American Journal of Respiratory and Critical Care Medicine meeting with the presentation at the International Conference of the American Thoracic Society 2018.

"Zephyr Valves are an important step forward in treating patients with severe emphysema who are permanently out of breath despite all the medications available, "said Gerard Criner, head of the Thoracic Medicine and Surgery Department's study, Lewis Katz School of Medicine at Temple University, Philadelphia , Pennsylvania, said in the press release

"I've seen Zephyr Valve-treated patients return to a more active life doing the things they enjoy As a doctor, I'm very pleased to have a new treatment that has the confidence of Recovering patients and changing their lives can be termed a term, "said Criner.

The Zephyr valve is contraindicated in patients with active lung infections; those who are allergic to nitinol, nickel, titanium or silicone; active smoker; and those who can not tolerate the bronchoscopic procedure.

The Zephyr valve received ground-breaking device designation and was approved by a pre-market approval application, which is the strictest type of device marketing application and is generally required for high-risk devices

Since 2007, more than 14,000 patients worldwide have had the Zephyr valve treated, the company said.

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