15:20 uur 01-07-2015

Door Lancet gepubliceerd onderzoek toont baten Pulmonx’ Zephyr Endobronchial Valve voor emfyseempatiënten aan

Pulmonx, leider in interventionele longgeneeskunde, heeft vandaag aangekondigd dat The Lancet resultaten van het klinische onderzoek BeLieVeR-HIFi heeft gepubliceerd. BeLieVeR-HIFi is de eerste placebo-gecontroleerde proef met minimaal invasieve apparatuur tegen emfyseem.

BeLiever-HIfi is een prospectief, dubbelblind en gerandomiseerd onderzoek waarin de behandeling van emfyseempatiënten met Pulmonx’ minimaal invasieve Zephyr®
Endobronchial Valve wordt vergeleken met een neppe bronchoscopische behandeling. Het onderzoek overtrof zijn primaire eindpunt en liet een verbetering van longfunctie van gemiddeld 20,9 procent aan bij patiënten die zijn behandeld met de Zephyr ten opzichte van de controlegroep. Het onderzoek toonde ook klinische en statistische significantie op enkele secundaire eindpunten, waaronder inspanningscapaciteit en problemen met uitademen.

Lancet Publication of Sham-Controlled Clinical Trial Shows Pulmonx’s Zephyr Endobronchial Valves Deliver Significant Benefit to Emphysema Patients

Pulmonx®, a leader in interventional pulmonology, today announced publication in
The Lancet of results from the BeLieVeR-HIFi clinical trial, the first
successful sham-controlled trial of any minimally invasive emphysema

BeLieVeR-HIFi is a prospective, double-blind, randomized,
sham-controlled trial comparing use of Pulmonx’s minimally invasive
valve treatment for severe emphysema patients – the Zephyr®
Endobronchial Valve
– to a sham bronchoscopy procedure. The study
exceeded its primary endpoint, demonstrating a 20.9 percent average
improvement in lung function (FEV1) in treated patients compared to
control patients. Clinical and statistical significance on several
secondary endpoints was also demonstrated, including exercise capacity
and gas trapping. There was no statistical difference between groups in

“We have been able to show, for the first time in a rigorous randomized
controlled trial, that endobronchial valves can improve lung function
and exercise capacity and achieve similar results to those seen with
lung volume reduction surgery in properly selected patients,” said Dr.
Nick Hopkinson, chief investigator of the study, in an announcement from
the National Institute for Health Research.

“In the study, we also saw that likely responders identified with the
Chartis system experienced better outcomes than those selected with CT
visual assessment alone,” he said.

Pulmonx Chief Executive Officer Glen
said, “An ever-growing body of evidence supports the benefits
of the Zephyr EBV in improving breathing and quality of life for
patients. These data also demonstrate the benefit of the combined use of
the Chartis system and Zephyr valves.”

Zephyr EBVs are tiny, one-way valves placed in the lungs to block
airflow to diseased regions in order to achieve lung volume reduction.
Following treatment, the remaining healthy regions are intended to
function more efficiently, enabling better breathing and improved
quality of life. Zephyr EBVs have been implanted globally in more than
10,000 patients. The Chartis system is utilized immediately prior to the
valve procedure to identify those patients that are most likely to
respond to endobronchial valve treatment.

About Pulmonx

Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx
is an interventional pulmonology company focused on developing
life-changing, cost-effective technologies that improve the lives of
patients suffering from lung disease worldwide. For more information,
visit www.pulmonx.com.

The Zephyr® EBV is an investigational device in the United States.
Limited by U.S. law to investigational use.

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