Americans suffering from severe emphysema now have a new treatment option available following the decision by the US Food and Drug Administration (FDA) to approve the Zephyr Endobronchial Valve, or Zephyr Valve. The device, marketed by Pulmonx Inc, is placed into diseased areas of the lungs by a doctor using a flexible bronchoscope, a procedure carried out in a hospital setting.
The new device works by preventing air from entering damaged parts of the lung and allows trapped air and fluids to escape. The valve closes during inhalation and opens during exhalation, relieving pressure in the lungs. The Zephyr Valve offers a less invasive form of treatment to patients with severe emphysema whose symptoms have not improved after taking medication.
“[Previous treatment options] have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients,” explained Tina Kiang, PhD, acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices at the FDA’s Center for Devices and Radiological Health. “This novel device is a less invasive treatment that expands the options available to patients,” she added.
Emphysema is one of the main forms of chronic obstructive pulmonary disease (COPD) and is estimated to affect as many as 3.5 million people in the United States, according to the Centers for Disease Control and Prevention. The condition damages the alveoli or air sacs of the lungs and is more common in patients over the age of 45. Emphysema is irreversible, so treatment focuses on minimizing progression of the condition and managing the symptoms.
Medication is one of the most common forms of treatment for emphysema, but other options include oxygen supplementation and surgery. Drugs used to treat emphysema are often in the form of inhalants, such as Symbicort (budesonide, formoterol), Spiriva Respimat (tiotropium), and Advair (salmeterol, fluticasone).
Approval for the Zephyr Valve was granted following an FDA review of a multi-center study of 190 patients with severe emphysema. After one year, almost half (48 percent) of patients with the valve experienced at least a 15 percent improvement in their pulmonary function scores, while only 17 percent of those in the control group achieved comparable results.
The device is contraindicated for patients with active lung infections, allergies to certain substances, active smokers, and those who cannot tolerate the bronchoscopic procedure. It was granted Breakthrough Device designation following an FDA review through the premarket approval review pathway, which is used for the highest risk class of devices.
Breakthrough Device designation is only granted after the device is shown to offer more effective treatment or means of diagnosis of a life-threatening or irreversibly debilitating condition. Furthermore, it must also either represent a technological breakthrough, have no approved or cleared alternative, offer significant benefits compared to approved alternatives, or demonstrate that availability will be in the best interest of patients.