National Institute for Excellence in Health and Care (NICE) Issues New Guidelines for COPD, Recommending Severe Patients to Evaluate Bronchoscopic Pulmonary Volume Reduction – Press Release



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REDWOOD CITY, Calif. – (Business Wire) – Pulmonx, leader in interventional pulmonary devices
announced today that the National Institute of Health and
Care (NICE) in the UK has broadened its
diagnosis and treatment of COPD to include which patients should be
referred for evaluation of reduction of bronchoscopic lung volume
Zephyr® Endobronchial Valves. Zephyr valves offer a
a minimally invasive treatment option that has been shown to improve
quality of life of patients with emphysema, allowing them to breathe
easier, have less shortness of breath and be more active.1

The main highlights of the NICE report include:

  • "Strong" recommendation to evaluate patients with severe COPD
    pulmonary volume reduction procedures, including the use of
    Zephyr Endobronchial Valves Based on Detailed Patient Analysis
    data on outcomes including improvement in lung function, quality of life,
    ability to exercise and survive.

  • "The criteria to refer patients for lung volume reduction
    the evaluation has been expanded because the treatment options now include
    endobronchial valves, a less invasive option that can benefit
    patients who were not candidates for more invasive surgeries
    treatments. The expansion of the criteria will lead to more referrals and
    better access to treatment for patients. "

  • Patients with emphysema who completed pulmonary rehabilitation,
    quit smoking, has a lung function less than 50% of predicted, may
    walk at least 140 meters in 6 minutes (a standard exercise test), and
    suffer from shortness of breath should be referred for lung assessment
    volume reduction procedures.

"NICE is respected globally for its in-depth reviews of evidence and
a systematic approach to the development of clinical guidelines. We thank
The complete NICE review of published clinical data from several Zephyrs
Randomized clinical trials of valves 1,2,3,4,5,6 and i believe it
guidance will be a valuable resource for providers and payers looking for
improve patient care, "said Glen French, president and chief executive officer
Officer of Pulmonx.

The guidelines committee also concluded that the endobronchial valve
It is likely to be cost effective compared to medical management.

"Patients with COPD suffer from shortness of breath and this results in
mobility and a lower quality of life. These patients need new, less
invasive options and I am very pleased to see NICE recognize this need
and recommending reduction of lung volume with Zephyr valves, "said
Professor Pallav Shah of Royal Brompton Hospital in London. "We expect
see other physicians refer more patients with COPD to
specialists will be evaluated for this less invasive option. "

More about Zephyr valves
Bronchoscopic Pulmonary Volume
reduction with the Zephyr valve is a unique procedure performed
through a bronchoscope; does not require cuts or incisions. During the
procedure, an average of four tiny valves are placed in the
block the diseased parts of the lungs. This allows the trapped air
until the lobe is reduced in size. Reducing hyperinflation and
preventing air from getting trapped in the diseased parts of the lung
allows the healthier parts of the lungs to expand and absorb more air.
This allows patients to breathe more easily and have fewer
lack of air1 Patients treated report
relief and the ability to go back to doing everyday tasks with ease.

The Zephyr valve was approved by the FDA in June 2018, through a
accelerated review because "it represents an innovative technology such as
device offers reduction of bronchoscopic lung volume without surgery and
their associated risks. This device offers clinically significant
significant advantages over the current standard of care and, therefore,
their availability is also in the best interests of patients. "Since 2007,
more than 15,000 patients were treated with the Zephyr valve
In all world. Treatment with Zephyr Valve is included in the treatment of emphysema
guidelines such as the Global Initiative for Chronic Obstructive Lung
Disease (GOLD) Global Strategy for Prevention, Diagnosis and Management
of COPD and is already recommended for routine use at National
Institute of Excellence in Health and Care (NICE) Interventional
Orientation of Endobronchial Valve Procedures (https://www.nice.org.uk/guidance/ipg600).

More on COPD and emphysema
Chronic pulmonary obstruction
pulmonary disease (COPD) is a progressive and potentially lethal pulmonary disease that
includes emphysema and chronic bronchitis. Over 65 million people
suffer from COPD globally and it is estimated that 3.2 million deaths
were caused by the disease in 2015 (5% of all deaths in the world).7
Despite taking the best medications available, many COPD and emphysema
hyperinflation, where air is trapped in
lungs and prevents fresh air from entering the lungs,
causing severe shortness of breath. Breathing becomes inefficient and
patients should work very hard just to breathe – doing normal activities,
like walking, eating or even bathing, difficult. There are few treatments
options for most patients with emphysema and there is no cure. Up until
now, the only other options for these patients were highly invasive
treatments such as lung volume reduction surgery or lung transplantation.

About Pulmonx
Based in Redwood City, California, and
Neuchatel, Switzerland, Pulmonx is the world leader in
pulmonary treatments for obstructive pulmonary disease. For more
information, visit www.MyLungsMyLife.com

NICE Guidelines: https://www.nice.org.uk/guidance/ng115/chapter/Recommendations#lung-surgery-and-lung-volume-reduction-procedures

U0663EN_A December 2018

1 Criner G. et al. Am J Respir Crit Care Med. 2018; 198
(9): 1151-1164.
2 Kemp S et al. Am J Resp Crit Care Med.
2017; 196 (12): 1535-1543.
3 Valipour et al. Am J Respir
Crit Care Med. 2016; 194 (9): 1073-1082 and data on file in Pulmonx.
4
Klooster K. et al. N Engl J Med 2015; 373: 2325-2336, + Supplement
Appendix
5 Davey et al. Lancet 2015; 386 (9998),
1066-1073.
6 Sciurba et al. N Engl J Med 2010; 363 (13),
1233-1244.
7 Global, regional and national life
expectancy, all-cause mortality, and cause-specific mortality for 249
causes of death, 1980-2015: a systematic analysis for the global burden
of the 2015 Disease Study. The Lancet 2016; 388: 1459-1544.

Meghan Oreste, 617-823-1441, [email protected]

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