Business Wire

FDA Approves Zephyr Endobronchial Valve for Treating Severe Emphysema

Jaa

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 ...

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.

About Pulmonx

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.

Contact information

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

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

Pierre Fabre Receives EU Approval for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in Adult Patients with Advanced BRAF-Mutant Melanoma20.9.2018 20:21Tiedote

Pierre Fabre today announced that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.1,2 The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway. "We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option”, said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. “All of us at Pierre Fabre are driven to make a real difference for patients. Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array BioPharma, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today’s

Clothesource Report Shows Retail Sales Aren’t Falling or Moving Online: Management’s Let Itself Get Misguided20.9.2018 20:19Tiedote

According to a new Clothesource report, “The Emperors’ Clothes” retail sales aren’t falling, and they’re not leaving physical stores. Both the UK’s Office of National Statistics and the US Bureau of the Census report higher retail sales than ever – with sales in physical stores still growing every year. Retailers just need to rely on their own customer understanding, recapture their self-confidence, and rediscover their traditional frugality. Among recent front-page stories have been Sears in the US hinting it’s about to go under and profits at Britain’s John Lewis falling 99%. But the well run clothing retailers are prospering. Primark goes from strength to strength: the biggest clothing specialists on either side of the Atlantic (Inditex and TJX) have just upped their sales and profit forecasts. So it’s not about consumer purchasing: The main problem lies with management, says Clothesource CEO Mike Flanagan in a new report “The Emperors’ Clothes”. They’ve lost touch with their custom

BCW Names Latin America Market Leaders20.9.2018 19:23Tiedote

BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced the appointment of market leaders in Latin America who will be responsible for business growth, client satisfaction and talent development. All market leaders report to Francisco Carvalho, President, Latin America, BCW. “BCW has a dominant presence in Latin America, thanks to Burson-Marsteller’s 40-year-history and expansive footprint across the region and Cohn & Wolfe’s strength in Brazil and Mexico,” said Carvalho. “This team has unmatched market knowledge, strong client relationships and deep commitment to talent, all of which is critical for our continued success in the region. Those strengths, together with our industry-leading expertise in delivering digitally driven integrated communications programs, make BCW a powerful partner for our clients.” All of BCW’s Latin America market leaders have been drawn from the legacy Burson-Marsteller organization and had been leading their respective markets, e

NavVis Achieves Breakthough 6D SLAM Indoor LiDAR Mapping With Velodyne’s 3D LiDAR Sensor20.9.2018 17:43Tiedote

On April 18th, 2018, NavVis released their M6, a fully-integrated, cart-based system designed for large-scale indoor mapping. The M6 utilizes VLP-16 sensors by Velodyne LiDAR, Inc., which allows it to produce a 3D map of the surrounding environment. Six cameras capture 360° immersive imagery and photorealistic point-clouds, resulting in high-resolution mapped images. NavVis developed this product in response to their customers’ request for a more versatile and sophisticated system which could be used effectively with uneven terrain. In addition to AEC professionals, construction companies and manufacturers can also draw benefits from the higher data quality provided by this enhanced innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005560/en/ NavVis M6 is a fully-integrated, cart-based system designed for large-scale indoor mapping. (Photo: Business Wire) The M6 was developed by NavVis after customers requeste

Steve Bannon’s New Documentary Film Trump @War Launches Free Online Access20.9.2018 17:34Tiedote

Trump @War in conjunction with its online distribution partner, The Western Journal, is pleased to announce that the full length HD feature film Trump @War is free and available to viewers worldwide at Trumpmovienow.com. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005553/en/ Watch free full-length feature film: trumpmovienow.com (Photo: Business Wire) “The Western Journal does great work and we are happy they are partnering with us,” stated Stephen K. Bannon. “It’s a film that every American, regardless of political belief, should watch. It’s a historic time for our country, and no one should be sitting on the sidelines during the upcoming elections.” Directed by Bannon and produced by Dan Fleuette, Trump @War is a retelling of the most significant election campaign in modern U.S. history and a look forward to the high-stakes midterm election in November 2018, which will cement President Trump’s legacy. “Steve Banno

GTIS Partners Grabs Top Spots in Prestigious GRESB Sustainability Ranking20.9.2018 17:24Tiedote

GTIS Partners LP (“GTIS”), a real assets investment firm headquartered in New York City, with offices in São Paulo, Los Angeles, San Francisco, Atlanta, Paris and Munich, today announced that the GTIS Brazil Real Estate Fund (“GTIS Brazil Real Estate Fund I”) has been recognized as 2018’s most sustainable private equity real estate investment fund in South America by the Global Real Estate Sustainability Benchmark (GRESB). This is the fourth year running the fund has clinched the top ranking. GTIS Brazil Real Estate Funds II and III took second- and third-place honors, respectively, matching the funds’ 2017 survey rankings. “Our across-the-board top-place rankings are a testament to the day-in, day-out efforts of the entire GTIS Brazil team, who’ve incorporated environmental, social and governance principles into their investment and management practices,” said Josh Pristaw, Senior Managing Director, Head of Capital Markets and Co-head of Brazil at GTIS Partners. “What we’re most proud

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