Business Wire

Zephyr Endobronchial Valves Improve Breathing, Quality of Life and Activity for Severe Emphysema Patients in US Pivotal Trial

Jaa

Pulmonx® Corp. today announced positive one-year results from the U.S. LIBERATE pivotal trial of the Zephyr® Endobronchial Valve, a minimally-invasive treatment for severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006139/en/

Zephyr Endobronchial Valves (Photo: Business Wire)

Zephyr Endobronchial Valves (Photo: Business Wire)

“The LIBERATE Study definitively proves that Zephyr Valves offer clinically meaningful improvements in three important areas for patients – the ability to breathe better, be more active, and enjoy an improved quality of life,” said the study’s lead investigator, Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University.

He continued, “All primary and secondary endpoints were met, with Zephyr Valve treatment showing significant improvement for patients across multiple measures of breathing and quality of life. The Zephyr Valve also demonstrated an acceptable safety profile given the magnitude of benefit seen in this study.”

The LIBERATE Study results were concurrently published in the American Journal of Respiratory and Critical Care Medicine and presented at the American Thoracic Society (ATS) 2018 International Conference by Dr. Criner.

A copy of the open access article can be viewed here.

LIBERATE is the first international, multicenter, randomized controlled trial to evaluate the effectiveness and safety of the Zephyr Endobronchial Valve out to one year in patients with severe heterogeneous emphysema with little to no collateral ventilation in the target lobe of the lung. The study randomized 190 patients at 24 sites, using a 2:1 randomization to Zephyr Valve treatment or medical management alone. Eligible patients were assessed for collateral ventilation using the Chartis® Pulmonary Assessment System, and only patients with little to no collateral ventilation in the target lobe were randomized.

One year after treatment, almost three times more patients treated with Zephyr Valves achieved the target improvement in lung function (≥15% increase in FEV1) compared to patients on medical management alone. In addition, Zephyr patients were able to do more daily activities, such as walking, doing chores and getting washed, with less shortness of breath than patients on medical management alone.

The most common side effect associated with the procedure was pneumothorax (air leak in the lung), which occurred in approximately one-third of patients. No intervention was required in approximately 20 percent of the incidents; the majority of the rest were addressed with standard medical management. Other side effects that happened less frequently included COPD exacerbation, pneumonia, respiratory failure and death.

Patients treated with Zephyr Valves had a statistically significant reduction in the rate of respiratory failure and a trend towards a reduction in the rate of COPD hospitalizations when compared to patients on medical management alone in the period following treatment to one year of follow-up.

Key outcomes at 12 months included:

  • Primary endpoint met:
    • Percentage of subjects with FEV1 improvement of ≥15% (a measure of breathing): 47.7% Zephyr Valve versus 16.8% control group (p<0.001).
  • Secondary endpoints met – the difference between the Zephyr Valve group and control group favored treated patients by:
    • FEV1 (a measure of breathing): 0.106L (p<0.001).
    • St. George’s Respiratory Questionnaire score (SGRQ, a measure of quality of life): -7.05 points (p=0.004).
    • Six-Minute Walk Distance (6MWD, a measure of exercise capacity): +39.3 meters (p=0.002).

The authors of the study commented that, “Bronchoscopic lung volume reduction with Zephyr EBV (endobronchial valves) is a breakthrough approach for reducing hyperinflation in patients with severe emphysema.” Furthermore, they noted that, “The occurrence of pneumothorax does not negatively impact clinical outcomes.”

Zephyr Valves are designed for emphysema patients who are often short of breath and doing less of the things they want to do despite regular use of COPD medications and/or oxygen. The tiny, one-way valves are placed in target airways of the lungs in a short procedure that does not involve cutting to occlude, or block off, the more diseased areas. This reduces hyperinflation and allows healthier parts of the lungs to take in more air and work more effectively. They are designed to be permanent, but can easily be removed, if necessary.

Over 12,000 patients worldwide have been treated with Zephyr Valves. This treatment option is included in emphysema treatment guidance issued by leading health organizations worldwide, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the UK’s National Institute for Health and Care Excellence (NICE). Zephyr Endobronchial Valves are the only endoscopic emphysema treatment with patient selection tools (Chartis and StratX® Lung Analysis Platform) that can accurately identify patients most likely to benefit from treatment, demonstrating 90 percent accuracy when used in combination.

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 Endobronchial Valve is an investigational device in the United States. Limited by U.S. law to investigational use only.

Contact information

Chronic Communications
Michelle McAdam, (310) 902-1274
michelle@chronic-comm.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Papa John’s Appoints Marvin Boakye as First Chief People Officer23.1.2019 18:02Tiedote

Papa John’s International, Inc., (NASDAQ: PZZA) one of the world’s largest pizza delivery companies, announced today the appointment of Marvin Boakye as its first Chief People Officer. He will serve as a member of the Papa John’s Executive Leadership Team and report to President and CEO Steve Ritchie. Boakye has more than 20 years of human resources experience, as well as expertise in change management and culture transformation. He has held human resources leadership roles for organizations across the United States, Canada and Latin America. Boakye joins Papa John’s after serving as vice president of human resources at petroleum company Andeavor in San Antonio, Texas, which was recently acquired by Marathon Petroleum. Prior to Andeavor, he was chief human resources officer for MTS Allstream, a telecommunications company now part of Bell Canada, and held senior human resources positions at Goodyear, Pulte Group and The Home Depot. “Boakye’s expertise will help us to continue to push Pa

Global Technology Association ISACA Launching Future-focused Initiatives in Its 50th Anniversary Year23.1.2019 17:22Tiedote

Now more than 450,000 engaged professionals and 140,000 members strong, global information technology association ISACA was founded by seven individuals as the EDP Auditing Association in California at the dawn of the information systems era—1969. Serving audit, governance, risk and cybersecurity professionals and their enterprises, today ISACA has a presence in 188 countries. Headquartered near Chicago, Illinois, USA, ISACA also established an entity in Beijing, China, last year, and acquired the CMMI Institute in 2016. In 2019—its 50th anniversary year—ISACA has adopted the theme, “Honoring Our Past. Innovating Our Future.” The organization has multiple initiatives planned to mark this milestone, including: Transforming IT Audit initiative—In February 2019, ISACA will launch a Transforming IT Audit microsite with resources to help IT auditors successfully navigate the future of the profession, including emerging areas like AI and blockchain, and featuring results from ISACA’s new glo

Wipro Ranked Third Fastest Growing Global IT Services Brand in 201923.1.2019 17:18Tiedote

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, has been ranked the third fastest growing global IT services brand in 2019 in a study conducted by Brand Finance, the world’s leading brand valuation firm. Wipro is also among the top 10 most valuable brands in the global IT services sector. According to Brand Finance’s IT Services annual report for 2019, which features 15 leading brands in the segment, Wipro has a total brand value of USD 4.002 billion, up 25% on year, emerging as one of the strongest brands in the category with an AA+ Brand rating. Brand Finance, in their official press release noted that Wipro’s significant investments in digital transformation capabilities, niche acquisitions, and a recent brand refresh, have propelled it to the third fastest growing brand in the segment. The report analyses the brand value and brand strength of the 5000 largest brands across 38 sectors in t

Velodyne Lidar and YellowScan Lead Drone Surveying Market for Highway Capacity Expansion23.1.2019 16:00Tiedote

Velodyne Lidar, Inc. today announced that the YellowScan Surveyor from YellowScan has utilized Velodyne’s groundbreaking sensor technology to generate precise mapping data for an infrastructure construction project on one of Central Europe’s busiest roadways. YellowScan Surveyor, an unmanned aerial vehicle (UAV) surveying system, improves upon previous time-intensive manual surveying processes by providing a more efficient method for collecting landscape data with increased precision and detail. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190123005054/en/ Ventus-Tech using YellowScan Surveyor, which includes Velodyne Lidar’s Puck™, to generate precise mapping data. (Photo: Business Wire) The project was conducted by Ventus-Tech using YellowScan Surveyor to collect data along a 47-kilometer segment of the M1 highway (E60, E65, E75) in northwestern Hungary. The data, gathered by 88 UAV flights over one month, enabled engine

PMI Among Elite Group of Companies to Score A for Climate Change23.1.2019 15:00Tiedote

Philip Morris International Inc. (PMI) (NYSE: PM) has been highlighted as a global leader on corporate climate action by environmental impact nonprofit CDP, achieving a place on the CDP Climate Change A List for the fifth consecutive year. As the only tobacco company to have scored an A, PMI has been recognized for cutting emissions, mitigating climate risks and developing the low-carbon economy, based on its 2018 disclosure to CDP. “Climate change is one of major concerns for humanity, and companies can make a difference. Just like we are leading our industry’s transformation toward a smoke-free future, we are focused on bettering every part of our business and supply chain to become a leader in sustainable business practices,” said André Calantzopoulos, Chief Executive Officer, PMI. The company’s efforts to reduce the environmental footprint of its operations focus on sustainable design in new facilities, energy efficiency in manufacturing processes, greener purchasing of electricity

STEMCELL Technologies Launches mTeSR™ Plus, a Next-Generation Culture System for Human ES and iPS Cell Maintenance23.1.2019 14:00Tiedote

STEMCELL Technologies has released mTeSR™ Plus, an enhanced version of mTeSR™1, the most widely published feeder-free human pluripotent stem cell (hPSC) maintenance medium. The new medium has undergone successful beta testing with several members of the Stem Cell COREdinates group and has completed rigorous in-house validation testing. Designed to promote a more consistent cell culture environment through sustained medium pH and stabilized components including FGF2, mTeSR™ Plus prevents the rapid onset of acidosis. This helps avoid conditions that have been associated with DNA damage, genomic instability, and growth arrest in hPSCs. The stabilization enhancements allow for greater hPSC expansion rates, enhanced culture morphology, and truly versatile feeding schedules including the option to skip weekends. “With the launch of mTeSR™ Plus, STEMCELL is positioned to set new industry standards in the pluripotent stem cell research field,” says Dr. Allen Eaves, President and CEO of STEMCEL

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme