The Global Initiative for Chronic Obstructive Disease (GOLD) recommends the use of endobronchial valves — such as the Zephyr Valve — for bronchoscopic lung volume reduction (BLVR) as a standard treatment for people with emphysema or less severe forms of chronic obstructive pulmonary disease (COPD).
GOLD considers there is “A” rated evidence (the best level available), including data from well-designed randomized clinical trials in a substantial number of participants, that support endobronchial valves as safe and effective for COPD treatment.
GOLD recommendations and guidelines for the diagnosis and treatment of COPD were recently announced in the “Global Strategy for Diagnosis, Management and Prevention of COPD” 2020 report.
“This GOLD rating is very important because it confirms that the body of evidence supporting endobronchial valves is significant, and supports the use of this intervention as standard of care for patients suffering from severe emphysema, a form of COPD,” Gerard Criner, MD, professor of medicine and chair of the department of thoracic surgery and medicine at Temple University, said in a press release.
The GOLD annual report is reviewed and revised by leading international physicians in the field of COPD, and is used worldwide by healthcare professionals as a “strategy document” and tool in the management and prevention of the disease.
The most recent report updates the use of endobronchial valves to GOLD standard of care for qualifying patients who have COPD. This decision was supported by the high quality data available demonstrating the enhanced efficacy and safety of endobronchial valves to reduce lung volume, compared to invasive surgery procedures.
Endobronchial valves, like the Zephyr Valve, are now distinguished from other bronchoscopic interventions, such as coils and vapor.
Zephyr valves are small, minimally invasive synthetic valves developed by Pulmonx Corporation to improve the breathing capacity of people with respiratory illnesses. Approved by the U.S. Food and Drug Administration (FDA) in July 2018, the valves block damaged lung airways, helping healthy lung tissue to work more efficiently.
On average, four valves are inserted in the patient’s airway through the use of a flexible bronchoscope — a tube that is inserted through the nose or mouth not requiring cutting or incisions — operated by a doctor in a hospital setting.
Once the patient inhales, the Zephyr valve closes, preventing air from entering the damaged part of the lung. During exhalation, the valve opens again to let out the trapped air, which relieves pressure inside the lungs.
This procedure reduces in size lung portions that are damage and, at the same time, allows the expansion of healthy lung tissue and a patient’s ability to take in more air.
“As a physician who treats these patients, the Zephyr Valves are the first FDA-approved minimally-invasive option we have had to help patients breathe easier once optimal medical therapy is no longer effective in controlling their symptoms,” Criner said.
Patients treated with Zephyr valves have reported immediate relief, with less shortness of breath and improved overall breathing, and a better ability to perform daily life tasks within weeks of treatment.
“GOLD is globally respected for providing in-depth evidence reviews and recommendations that impact patient treatment around the world. We are very pleased to see GOLD give endobronchial valves, like our Zephyr Valve, an evidence ‘A’ rating after a thorough review of published clinical data,” said Glen French, president and CEO of Pulmonx.
“This level of evidence is an important factor for providers and payers who are seeking to deliver the best treatment options for patients with severe emphysema, a severe form of COPD,” French added.
According to Pulmonx, more than 15,000 patients have been treated with the Zephyr Valve worldwide since 2007.