FDA Approves Zephyr Endobronchial Valve for Treating Severe Emphysema
Pulmonx® Corp. announced today that the U.S. Food and Drug Administration (FDA) has approved the Zephyr® Endobronchial Valve System for treating severe emphysema patients. The Zephyr Valve is the first minimally-invasive device approved in the United States for treating patients with severe emphysema, a progressive and life-threatening form of chronic obstructive pulmonary disease (COPD).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180629005666/en/
The Zephyr Endobronchial Valve is proven to help patients breathe easier and enjoy more active lives. (Graphic: Business Wire)
The approval is based on positive clinical data from the pivotal LIBERATE Study and two other multicenter randomized control trials. In the LIBERATE study, patients treated with Zephyr Valves were able to breathe easier, be more active and energetic, be less short of breath, and enjoy a significantly improved quality of life compared to patients who received medical management alone.
As stated in the Summary of Safety and Effectiveness Data, the FDA granted the Zephyr Valve an expedited review because it “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. This device offers significant clinically meaningful advantage over the current standard of care and, therefore, its availability is also in the best interest of patients.”
“Zephyr Valves are a major step forward in treating severe emphysema patients who consistently feel short of breath despite all the medications we can offer. I have seen Zephyr Valve-treated patients getting back to a more active life doing the things they enjoy. As a physician, it is very gratifying to have a new treatment that can restore a patient’s confidence and change their life for the long term,” said Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, and lead investigator for the LIBERATE Study.
More than 15 million Americans suffer from COPD, and 3.5 million of those patients have emphysema.1 Despite using COPD medications, over one million emphysema patients continue to suffer symptoms of hyperinflation, in which air becomes trapped in the lungs and prevents new air from coming in, causing severe shortness of breath.2 The inability to get enough air often prevents these patients from doing simple daily activities, such as bathing, getting dressed, performing household chores and walking, without pausing to catch their breath. Until now, the only other options for these patients were highly invasive treatments such as lung volume reduction surgery or lung transplantation.
During a bronchoscopic procedure requiring no cutting or incisions, tiny Zephyr Valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation. This helps the healthier parts of the lungs to expand and lifts pressure off the diaphragm, thereby decreasing shortness of breath and making breathing easier.
Patients most likely to benefit from Zephyr Valve treatment can be identified with assessment tools also offered by Pulmonx. Physicians use the Pulmonx Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform to help identify potential responders to Zephyr Valve treatment.
“It is gratifying to be able to tell the many US patients who have contacted us that help is on the way. We thank FDA for its swift review of the Zephyr Valve. By combining the Zephyr Valves and our patient selection tools, we are bringing precision medicine to the treatment of severe emphysema,” said Pulmonx CEO Glen French.
Since 2007, more than 14,000 patients have been treated with the Zephyr Valve worldwide. Zephyr Valve treatment 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).
The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.
Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is the world leader in interventional pulmonology treatments for obstructive lung disease. For information on the Zephyr Valve, visit www.MyLungsMyLife.com. For more information on Pulmonx, visit www.pulmonx.com.
1. Centers for Disease Control and Prevention. Summary Health Statistics
Tables for U.S. Adults: National Health Interview Survey 2016. https://www.cdc.gov/nchs/fastats/copd.htm.
Accessed June 22, 2018.
2. Soriano JB, Lamprecht B, Ramirez AS, et al. Mortality prediction in chronic obstructive pulmonary disease comparing the GOLD 2007 and 2011 staging systems: a pooled analysis of individual patient data. Lancet Respir Med. 2015;3(6):443–50.
Chronic Communications, Inc.
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
Bearingpoint Acquires Inpuls, a Leading Data Specialist in Belgium14.11.2018 12:20 | Tiedote
Management and technology consultancy BearingPoint has made a strategic move in the Belgian consulting market by acquiring Inpuls, a leading data specialist. The acquisition contributes to BearingPoint’s overall growth objectives, strengthens its presence in Belgium, and enhances its data capabilities. “The acquisition of Inpuls pays into two core elements of our corporate strategy: we enrich our portfolio focused on digitalization, regulation, and analytics; we concentrate on European clients, enabling them to become global leaders. Against this background this acquisition doubles our size in Belgium, and just as important, our clients now have Inpuls’s data expertise. We believe data is at the heart of digital transformation and creates value propositions and competitive advantages for our clients,” said Kiumars Hamidian, Managing Partner of BearingPoint. Founded in 2014, Inpuls is a Belgian consultancy specialized in data strategy, data governance, privacy, Big Data, and analytics.
GSMA Announces New Developments for MWC19 Barcelona14.11.2018 12:00 | Tiedote
The GSMA today announced further details for MWC19 Barcelona (formerly Mobile World Congress), including additional keynote speakers, participating companies, programmes and events. Taking place 25-28 February 2019, with events being staged at Fira Gran Via, Fira Montjuïc and La Farga L’Hospitalet, MWC19 Barcelona is set to attract more than 107,000 professionals from over 200 countries and territories. “We have an amazing show lined up for February, with more than 2,400 companies participating across the exhibition, four days of conference programming and so many other events and activities taking place at MWC19,” said Michael O’Hara, Chief Marketing Officer, GSMA. “With in-depth examination of topics such as 5G, artificial intelligence, Internet of Things, content, security and many others, MWC Barcelona, now more than ever, is the “must-attend” industry event.” Execs from ARM, Huawei, KT and Orange Confirmed for Keynotes The GSMA announced several newly confirmed keynote speakers fo
Exclusive Group and Arcitura Education Team Up for Channel Partners to Profit from Cloud Skills Gap14.11.2018 11:00 | Tiedote
Exclusive Group, the value-added services and technologies (VAST) group, today announced an agreement to become the only global provider of Arcitura Education’s renowned, vendor-neutral Cloud Certified Professional (CCP) accreditation programme. The move underlines the unique value of Exclusive Group’s ‘Cloud Competency Centre’ and will enable thousands more channel partners to develop the skills necessary to meet evolving customer challenges around cloud transformation and convert significant additional revenues. “Channel partners can’t afford to lose their market edge through a lack of cloud competency – they need new skills to complement their experience and technology knowledge so that customers carry on seeing them as relevant to their future,” said Andre Dieball, Global Director, Services at Exclusive Group. “70-80% of enterprises are experiencing cloud skills crises that risk crucial transformation projects going over time and over budget. These projects, collectively worth bill
Kenetic Bucks Crypto Market Trend with YTD 77% Returns in Investment Portfolio14.11.2018 10:37 | Tiedote
Kenetic, a blockchain investment and advisory firm based in Hong Kong, has revealed that its proprietary investment portfolio has recorded year-to-date returns of 77 percent as of October 31, 2018, against a backdrop of major losses in the cryptocurrency market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113006323/en/ After hitting its record high in December 2017, Bitcoin has fallen over 50 percent in 2018 and the overall crypto market is down around 65%. Kenetic’s proprietary investment portfolio is comprised of its best ideas that have undergone thorough due diligence by its experienced investment team. Its alpha-generating strategies are largely focused on early stage investments, catalyst driven events and macro themes, complemented by prudent risk management and proprietary in-house trading tools. “As active leaders in the global blockchain community, we see where the strongest investment opportunities lie and r
Smiths Detection State-of-the-Art Checkpoint Lanes Chosen for Israeli Airports14.11.2018 10:30 | Tiedote
Smiths Detection and its local distributor, Eastronics, have been selected by the Israel Airport Authority (IAA) to supply 32 advanced checkpoint lanes for Ben Gurion Airport and the new Ramon International Airport, which is due to open in 2019. These latest, highly functional lane designs from Smiths Detection incorporate automated tray return and diversion and were developed to improve operational efficiency and passenger experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181113005810/en/ “Automation plays a key role in streamlining screening by literally keeping things moving and the result is increased throughput, lower per capita costs and a passenger friendly process,” explained Tony Tielen, Vice President EMEA, at Smiths Detection. “With the help of Eastronics, we were delighted to be able to meet IAA’s stringent requirements for this extensive project, which could have a significant impact on maintaining flow
CHTF 2018 Opens, Gathering Global Enterprises and Entrepreneurs14.11.2018 09:00 | Tiedote
The 20th China Hi-Tech Fair (CHTF 2018) kicked off at the Shenzhen Convention and Exhibition Center on November 14, 2018. By showcasing cutting-edge high-tech products and technologies of enterprises and institutions from around the world, CHTF 2018 remained a trend setter in the high-tech industry. A large number of technology companies have emerged from CHTF in the past two decades. In its 20th year, CHTF 2018 attracted the world's top experts and scholars, and gathered multinational corporations, Fortune 500 companies and unicorn enterprises to showcase the latest technical developments. Chinese giants included China Mobile, China Unicom, China Telecom, China Electronics, CRRC; multinational companies included Suez, Foxconn, Ricoh, Baidu, Tsinghua Tongfang, TCL, Sogou, BOE; unicorn enterprises included SenseTime, iQiyi, Royale, Orbbec, Qiniu Cloud, BITMAIN, etc. In addition, three leading AI chip companies, namely Cambrian, Horizon Robotics and Deephi Tech, were also involved. The C
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