UK Adds Endobronchial Valves to Standard of Care for Severe Emphysema

UK Adds Endobronchial Valves to Standard of Care for Severe Emphysema

The U.K.’s National Institute for Health and Care Excellence (NICE) has updated its guidelines to include endobronchial valves as an appropriate routine treatment for severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD).

This announcement comes on the heels of positive safety and effectiveness data from multiple randomized clinical trials of Pulmonx’s Zephyr Endobronchial Valves (EBV).

In the U.K., approximately 400,000 people live with emphysema, a condition characterized by damage to the air sacs in the lungs that allows air to escape.

Zephyr EBVs are small, minimally-invasive valves placed in the airways of the lungs that block the damaged regions. This allows the healthy lung regions to work more efficiently, and leads to improved breathing and a better quality of life for the patient.

“In light of the high burden of symptoms, progressive nature of emphysema and poor prognosis for patients, the NICE decision means that patients with severe emphysema should be referred to specialists to determine if they are good candidates for endobronchial valves or other interventions,” Pallav Shah, MD, respiratory medicine physician at Royal Brompton & Harefield Hospital and Chelsea and Westminster Hospital, said in a press release.

Four randomized clinical trials were conducted to determine the safety and effectiveness of Zephyr EBV. Results from these studies garnered significant evidence that Zephyr EBV improves lung function, exercise tolerance and quality of life in emphysema patients with no collateral ventilation.

Most recently, the TRANSFORM trial (NCT02022683) showed that Zephyr EBV improved lung function in patients with severe emphysema.

Zephyr EBVs have been implanted in more than 12,000 patients worldwide over the past 10 years. They are used routinely in both Europe and Australia as a treatment for severe emphysema. Recently, the Dutch government announced that EBVs are an effective treatment in adult patients with severe emphysema and that the treatment costs will be covered by the government.

The device also has been included in international guidelines as an acceptable treatment method, including in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.

“These decisions will increase patient access to our proven and minimally-invasive Zephyr technology, which has the potential to significantly improve the quality of life for patients,” said Glen French, Pulmonx CEO.

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  1. Lorri Arnett says:

    I signed up with a clinical trial for this product (or one similar). Unfortunately, and sadly, I was not accepted because my lungs were not talking to one another. For whatever reason, my lungs do not work together in sync with each other. I cannot tell you how depressed I was at this outcome. I had quit smoking in order to qualify for this clinical trial.I postponed going through pulmonary rehabilitation in order to qualify for this clinical trial. I went through so many tests as part of qualifying for this clinical trial. I was raising 3 great-grandchildren at the time, and I wanted so badly to get these valves inserted into my lungs…which I “just knew” would allow me to live long enough to see these 3 kids at least enter college.
    I pray that whatever part of the protocol of this trial prevented my participation is changed so that my out-of-sync lungs (and, now my age) do not prevent my getting these valves when they are approved for use in the United States.

  2. Dave Struder says:

    I have three years of an ongoing trial. Stage 3 copd Dx 12/2014 with just 20% lung function. Poor prognosis… Yet have not used any o2, no puffer, and no steroids since 2/2015.
    I claim victory over copd. Lungs have been restored to a great degree and am able to walk 18 holes of golf barring some trauma to wrists etc. All with no tether, no steroids no puffer.
    My concern with blocking damaged tissue when it appears evident I have not just beat copd but proven all usual and customary Tx is useless in comparison.
    Targeted Cannabinoid Therapy is no secret to my friends, why a great.organization like yours has not been informed of the science simply amazes me. I’m willing to help at your interest.

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