Pulmonx Corp today announced its filing of a Premarket Approval (PMA) application with the FDA for the Zephyr Endobronchial Valve (EBV), a minimally-invasive and removable device designed to treat severe emphysema, an advanced form of COPD. The Zephyr EBV is the only device designed for emphysema that has a clinically-validated diagnostic tool – the Chartis System – which can identify likely responders in order to optimize patient outcomes.
The filing was based on the successful execution of Pulmonx’s pivotal IDE trial, the LIBERATE Study, a landmark randomized controlled trial that enrolled 190 patients with severe emphysema at 24 centers in the US and Europe. The trial endpoints at one year included measures of lung function, exercise tolerance and quality of life.
Three previous randomized controlled trials of the Zephyr EBV (TRANSFORM, IMPACT and STELVIO), in addition to LIBERATE, provide a robust body of evidence showing that the treatment improves breathing, exercise capacity and quality of life, while demonstrating long-term safety, in emphysema patients with little or no collateral ventilation as assessed with the Chartis System1,2,3.
Emphysema causes damage to the alveoli, the air sacs in the lungs, which allows air to escape and prevents patients from taking full breaths. This chronic breathlessness makes even the simplest daily activities difficult, such as washing, eating, walking and household chores, and often leads to patients becoming housebound and depressed. In fact, the quality of life for emphysema patients is worse than that for lung cancer4. As an incurable, progressive disease, emphysema can lead to early death without effective treatment options.
COPD is the third leading cause of death in the US, behind heart disease and cancer5. Because it is often underdiagnosed, it is estimated that between 12 million and 24 million Americans have COPD, costing the U.S. almost $50 billion in direct and indirect costs5. Almost five million Americans have a severe form of COPD known as emphysema5.
“We are proud to be leading the industry in developing rigorous and robust clinical evidence for this technology, which is consistently demonstrating the value of Zephyr EBVs in improving the lives of emphysema patients,” said Pulmonx CEO Glen French. “Assuming a positive reception from the FDA, we look forward to bringing the Zephyr EBV to US pulmonologists and their emphysema patients who are desperately seeking new treatments.”
Zephyr EBVs are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways in the lungs to block diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions of the lung can function more efficiently, enabling better breathing and an improved quality of life for patients.
Zephyr EBVs are widely used Europe, Australia, Asia and South America as a treatment for severe emphysema. Over the past 10 years, more than 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients. To view a video of the Zephyr EBV procedure, click here.
The Zephyr EBV is an investigational device in the United States. Limited by US law to investigational use only.
References
- Klooster K, Ten Hacken NHT, Hartman JE, Kerstjens HAM, Van Rikxoort EM, Slebos DJ. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med 2015; 373:2325-2335.
- Kemp SV, et al. A multicenter RCT of Zephyr Endobronchial Valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med 2017;https://doi.org/10.1164/rccm.201707-1327OC
- Valipour A, et al. Endobronchial valve therapy in patients with homogeneous emphysema. Results from the IMPACT study. Am J Respir Crit Care Med 2016;194(9):1073-1082.
- Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax 2000;55(12):1000-1006.
- American Lung Association. Trends in COPD (Chronic Bronchitis and Emphysema): Morbidity and Mortality;March 2013. http://www.lung.org/assets/documents/research/copd-trend-report.pdf
I was hoping I could get some help! I have stage 4 emphysema. I am 63 and was hoping there was a possibility I could utilize the help from the Zephyr here in Texas. Please respond back with any help, this would be greatly appreciated.
Sincerely,
Drew Westbrook
512 264-9392
Hi Drew, the device is currently investigational only. Reaching out to Pulmonx directly would be your best option for more info on its availability: https://www.pulmonx.com/us/contact/
What would be a normal time frame for the FDA approval process. Once the approval occurs would that mean most insurance would cover the procedure. Seems using the endobronchial valves would be much more cost effective than the lung reduction surgery so the insurance company would prefer it.
I had ebv inserted in London by dr prof Pallav Shaw md
Procedures were October 2017. Unfortunately I had severe complications which is possible in any medical procedure. The results are nothing less than wonderful
I have stage 4 copd and until the survey I could barely walk from by den to the bathroom. I can walk around publix and Home Depot for hours. I am smart enough to pace myself however my life has changed. I seldom need oxygen. No more flattening of my diaphragms or hyperinflation on chest X-ray. I still have some days where I get a little dydoneic but very seldom. I owe dr Pallav Shaw my life. He can be found at Harley st clinic which is a hospital in London. He has been performing this procedure for 17 years with remarks results
The guru in the USA is dr Frank Sciurba who can be located at Pittsburgh university medical center. He was the old involved in the research study in the USA. Fr Sciurba followed me up post iteratively. By Pft we’re greatly improved and this surgery is priceless
If you require info on the procedure I will be pleased to discuss the procedure with anyone
Scottie Steinberg RN 562-767-4431