Pulmonx yesterday released one-year results from the pivotal trial of its Zephyr endobronchial valve designed to treat patients with severe emphysema from chronic obstructive pulmonary disease, touting significant improvements in lung function and quality of life.
Results from the study were presented at the American Thoracic Society 2018 international conference and published in the American Journal of Respiratory and Critical Care Medicine, the Redwood City, Calif.-based company said.
“The Zephyr valve is a treatment for patients with COPD who have emphysema and severe hyperinflation. Hyperinflation is when too much air is left in your chest at the end of the breath, so you feel like your suffocating and can’t take a bigger breath. The valve is designed to decrease the volume of the chest, especially in the areas where the worst emphysema is, to allow other pieces of the lung that work better, to work better. It also decreases the air in the chest and allows the heart and the respiratory muscles in the chest wall to work better,” lead investigator Dr. Gerard Criner of Temple University’s Lewis Katz School of Medicine, who presented the results, told MassDevice.com in an interview.
The study enrolled a total of 190 patients across 24 sites with two-to-one randomization for treatment with the Zephyr valve and the control arm, Dr. Criner said. Patients in the trial were assessed for collateral ventillation using the company’s Chartis pulmonary assessment system, and included only patients with little to no collateral ventillation in the target lobe.
“This study was the largest, longest study to use a less-invasive or minimally-invasive technique using these one-way valves,” Dr. Criner said.
Dr. Criner said that after one year, patients treated with the Zephyr valves were significnatly more likely to show improvements in lung function, measured as forced expiratory volume in one second, or FEV1.
“Patients that were treated had about a three times greater likelihood of having significant improvement in FEV1, more than 15% in 45% of the treated group compared to 11% of the control,” Dr. Criner said.
Additionally, patients treated with the Zephyr reported more ease in performing daily activities, including improving walking distances by 34 meters as compared to the control group.
The most common side effect as a result of the procedure was pneumothorax, or air leaks in the lung, which occurred in approximately 33% of patients, though no intervention was required in 20% of those incidents and the majority of the remaining incidents were addressed with standard medical management, Pulmonx said in a press release.
Dr. Criner said that the therapy worked well because, on average, patients treated with the Zephyr valve had the ability to decrease air in the affected lung lobes by about 1 liter, which resulted in an approximately half-liter reduction in the physiologic measures of air trapping overall.
“Its good news for patients with emphysema and COPD. I’m at the American Thoracic Society and this study exemplifies that there are new therapies that are being developed for patients with this disease. So patients should talk to their doctors and have hope that there is new therapies coming out to try to help them,” Dr. Criner said.
The study could mean big improvements in the quality of life for patients in the US living with severe emphysema from COPD, Pulmonx marketing & biz dev VP Beran Rose told MassDevice.com.
“There have been studies that show that, for these late-stage emphysema patients, their quality of life is actually worse than that of an end-stage lung cancer patient. So, it’s a really horrible disease,” Rose said.
There are between two and three million of those patients in the US, Rose added, of which which Pulmonx believes about half a million of would qualify for treatment with the Zephyr valves.
“The Zephyr endobronchial valves are designed for emphysema patients who have this severe shortness of breath – and they’re doing less of the things that they want to do, and are slowly withdrawing from the world in order to manage their symptoms. They say, “If I just do less, maybe I won’t have these breathing programs.” As a result, they have less exercise and they are more socially isolated and that causes them to get worse and they get into this negative downward spiral. Our valves are intended to interrupt that and help them get back to doing activities,” Rose said.
Rose is optimistic that the study will move the company a step closer to regulatory approval the in US, and opening the therapy, which has been available and commercially used in Europe for over a decade, to a new pool of patients that could significantly benefit from it.
The Zephyr valves, and associated technology for identifying patients eligible for procedures with the valves, have been the focus of multiple previous studies and have become recommended in many major guidance documents outside the US, Rose said. The therapy has won support from the U.K.’s National Industry for Clinical Excellence and a number of international pulmonary organizations as a standard of care for severe COPD and emphysema patients Rose added.
“I think what’s interesting is if you look at the US, is that we’re kind of coming to the party pretty late. That’s, in part, because it took us a while to finish the Liberate study, but one of the fortunate things for us in coming to the US market now is that we really know who the right patient is, how to treat them, what it takes to have consistent good outcomes,” Rose said. “So, it’s really exciting to be able to bring in technology to market with that kind of clinical data behind it. You often end up with one good study and very little else, so we’re excited to be able to charge forward and help patients.”
Rose said that the company is hopeful that the Zephyr valves could see FDA approval by the end of the year.
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