FDA Clears Zephyr Endobronchial Valve to Treat Severe Emphysema

Megan Brooks

Disclosures

June 29, 2018

The US Food and Drug Administration (FDA) has approved the Zephyr Endobronchial Valve (Pulmonx Corp) to treat breathing difficulty associated with severe emphysema.

"Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients. This novel device is a less invasive treatment that expands the options available to patients," Tina Kiang, PhD, acting director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA's Center for Devices and Radiological Health, said in a news 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 news release.

During a bronchoscopic procedure, Zephyr valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation, allowing the healthier parts of the lungs to take in more air and work more effectively, the company explained. 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 that included 190 patients with severe emphysema for whom there was little to no collateral ventilation in the target lobe of the lung.

In the study, 128 patients were 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 medical management only.

At 1 year, significantly more of the patients who were treated with Zephyr valves experienced at least a 15% improvement in forced expiratory volume in 1 second, the primary endpoint (47.7% vs 16.8%; P < .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 to patients who received medical management alone.

The most common side effect associated Zephyr valve treatment was pneumothorax, which occurred in roughly one third of patients. No intervention was required in about 20% of the incidents; the majority of the rest of such cases were addressed with standard medical management. Other side effects, which occurred less frequently, included COPD exacerbation, pneumonia, respiratory failure, and death.

Findings from the LIBERATE study were published May 22 in the American Journal of Respiratory and Critical Care Medicine to coincide with presentation at the American Thoracic Society 2018 International Conference.

"Zephyr Valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer," the study's lead investigator, Gerard Criner, MD, chair and professor of thoracic medicine and surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, said in the news release.

"I have seen Zephyr Valve–treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient's confidence and change their life for the long 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 smokers; and those who are not able to tolerate the bronchoscopic procedure.

The Zephyr valve received breakthrough device designation and was approved through a premarket approval application, which is the most stringent 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.

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