Pulmonx wins FDA approval for Zephyr endobronchial valve

The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from entering the diseased alveoli but allow it to escape during exhalation. The federal safety watchdog said it granted Zephyr’s PMA based on a 190-patient study comparing treatment with Zephyr, plus standard medical management and pulmonary rehabilitation, to treatment with standard medical management and rehab only. The trial’s benchmark was at least a 15% improvement in pulmonary function score. Some 47.7% of patients in the Zephyr arm met that mark, compared with 16.8% of the control arm, according to the FDA. Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain, the agency said. “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 reduc...
Source: Mass Device - Category: Medical Devices Authors: Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Pulmonx Source Type: news

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