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Now onto the reason you're here: Medical Device Monday!
Recently, FDA approved a novel device called the Zephyr Endobronchial Valve from Pulmonx Inc. This Zephyr Valve is intended to be used in patients who have difficulty breathing due to emphysema.
It is estimated that about 3.5 million American adults have been diagnosed with emphysema, a chronic obstructive pulmonary disease (COPD) due to damaged alveoli in the lungs. Alveoli are the tiny air sacs of the lungs which allow for rapid gaseous exchange. Unfortunately, the lung damage that results from emphysema and severe emphysema is irreversible. The damaged alveoli can cause the used air to become trapped in the lungs during exhalation. The trapped air may cause diseased parts of the lung to increase in size, which puts pressure on the healthier sections of the lung. This in turn makes it extremely hard to breathe, ultimately resulting in the body being deprived of necessary oxygen.
Treatment options for people with emphysema are extremely limited, and the treatments options that are available are typically invasive and have high risk. These treatments include lung surgeries like volume reduction or lung transplants. Tina Kiang, Ph. D., from the Division of Anesthesiology in FDA’s Center for Devices and Radiological Health, says that the Zephyr Endobronchial Valve “is a less invasive treatment that expands the options available to patients.” The device was granted Breakthrough Device designation, expediting the agency’s review of the device. Because the Zephyr device offers significant advantages over other existing alternatives, and due to its unique technology, this device earned its breakthrough status.
Here is how it works:
The Zephyr Valves are the size of a pencil eraser and are placed into the diseased areas of the lung using a flexible bronchoscope. The valves are intended to prevent air from entering the damaged parts of the lung, and also allow trapped air and fluid to escape. The one-way valves close during inhalation, and open when exhaling, letting out trapped air and relieving pressure.
Data reviewed by FDA included a study that involved 190 severe emphysema patients; 128 of those patients were treated with Zephyr Valves, and the remaining 62 patients were a control group who received medical management only. The results were measured by the number of patients in each group that had at least 15 percent improvement in the area of pulmonary function. In one year of the study, 47.7 percent of the experimental group experienced at least a 15 percent improvement, while only 16.8 percent of patients in the control group experienced the same amount of improvement.
While this device is proving to be extremely helpful for patients with severe emphysema, the Zephyr Valve is contraindicated for patients with active lung infections, active smokers, and those who have allergies to specific metals.
This is yet another example of how FDA is helping speed innovation by helping get breakthrough devices on the market. Based on our calculations, this file was submitted to FDA on January 2, 2018, and was approved on June 29, 2018. That means this company got approval in 176 days! Congratulations to Pulmonx and to the many patients whose lives will be improved thanks to this medical device!