Business Wire

New Data from Two Multi-Center Randomized Clinical Trials Demonstrate That Zephyr Endobronchial Valves Deliver Benefit to Both Heterogeneous and Homogenous Emphysema Patients without Collateral Ventilation

23.5.2017 18:45 | Business Wire

Del

Pulmonx®, Inc. today announced the results of two multi-center, randomized clinical trials showing clinically meaningful improvements in lung function after treatment with the Zephyr® Endobronchial Valve (EBV) in emphysema patients without collateral ventilation. Six-month data from both the TRANSFORM and IMPACT trials, presented this week at the American Thoracic Society international conference, demonstrate that Zephyr valves provide positive benefits in these patients with either homogeneous or heterogeneous distribution of emphysema.

Zephyr Endobronchial Valves are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways of the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions can function more efficiently, enabling better breathing and an improved quality of life for patients.

In the clinical trials, patients were selected based on the absence of collateral ventilation (airflow between regions of the lung that bypasses normal airways), which was assessed in the trials using the Chartis Pulmonary Assessment System from Pulmonx. The effectiveness of endobronchial valves is dependent on selection of an area of the lung without collateral ventilation for treatment.

The TRANSFORM study, a multi-center, prospective, randomized, controlled trial, evaluated 97 patients with heterogeneous (more focally-distributed) emphysema at 17 centers in six countries. Patients were randomized 2:1 to Zephyr valve treatment versus standard of care. The authors concluded that Zephyr valve treatment in heterogeneous emphysema patients without collateral ventilation confers clinically and statistically significant sustained benefits, with improvements in lung function, exercise capacity and quality of life.

At six months, 56.3 percent of patients treated with Zephyr valves achieved a 12 percent or greater improvement in lung function (FEV1) from baseline, when compared to 3.2 percent of patients in the control group. The lung function (FEV1) in the Zephyr valve-treated group was on average 29.3 percent higher than the control group. Improvements of a similar magnitude were observed between groups in exercise capacity (measured by Six-Minute Walk Distance, or 6MWD), with Zephyr valve-treated patients improving upon the control group by 78.7 meters. Finally, the quality of life of Zephyr valve treated patients improved by 6.5 points over control in the St. Georges Respiratory Questionnaire (SGRQ) score.

“The magnitude of benefits to patients in this pan-European trial are dramatic and reinforce results published from prior single center studies,” said Samuel Kemp, MD, principal investigator and respiratory physician at the Royal Brompton Hospital, London, UK. “Using Chartis for patient selection enabled us to accurately identify patients without collateral ventilation, which is a key predictor for good outcomes with this device.”

The IMPACT study enrolled 93 patients with severe homogeneous (more diffusely-distributed) emphysema who were randomized 1:1 to Zephyr valve treatment versus medical management. Consistent with the previously published three-month data, the improvements remained statistically and clinically significant at six months with Zephyr valve treated patients experiencing improvements over control for FEV1 of 16.3 percent (p<0.001), an increase in 6MWD of 28.3 meters (p=0.016), and an improvement in the quality of life based on a decrease in the SGRQ score of –7.5 points (p<0.001).

The most common side effect of the Zephyr valves in both studies was pneumothorax (20 to 26 percent in the treated group) and chronic obstructive pulmonary disease exacerbations (11 to 28 percent versus 6 to 18 percent in the control group) in the immediate post-procedure period. Both were addressed with standard medical management.

Two prior randomized controlled trials of the Zephyr valve in patients without collateral ventilation (the STELVIO and BeLieVeR-HIFi trials) also support the ability of Zephyr valves to significantly improve lung function, exercise tolerance and quality of life.1,2 Additional published clinical data demonstrate sustained patient benefits out to five years3 and suggest potential survival benefits at five and 10 years post-treatment,4,5 indicating a possible slowing in disease progression.

“For patients with severe emphysema, there were previously few therapeutic options,” said Pulmonx Chief Executive Officer Glen French. “Now, we have consistent data from four randomized studies showing that, regardless of disease heterogeneity, when patients are selected for the absence of collateral ventilation, they can gain substantial benefits in quality of life, exercise capacity and lung function with Zephyr valves.”

Over the past 10 years, approximately 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients. To view a video of the Zephyr EBV procedure, click here.

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.

1.  

Klooster K, Ten Hacken NHT, Hartman JE, Kerstjens HAM, Van Rikxoort EM, Slebos DJ. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med 2015; 373:2325-2335.

2.

Davey C, Zoumot Z, Jordan S, McNulty W, Carr D, Hind M, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet 2015; 386: 1066–1073.

3.

Venuta F, A Marco, D Daniele, Coloni G, et al. Long-term follow-up after bronchoscopic lung volume reduction in patients with emphysema. Eur Respir J 2012; 39: 1084–1089.

4.

Hopkinson NS, Garner J, Kemp S, et al. Survival after Endobronchial Valve Placement for Emphysema: A 10-Year Follow-up Study Eur Respir J 2016; 194: 519-521.

5.

Gompelmann D, Benjamin N, Bischoff E et al. Survival after endoscopic valve therapy in patients with severe emphysema. Eur Respir J 2016 (ERS 2016 Abstract #OA472).

Contact information

Chronic Communications
Michelle McAdam
(949) 545-6654 or (310) 902-1274
michelle@chronic-comm.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

The Valence Group Issues Fairness Opinion to SK Capital in Connection with Archroma18.8.2017 13:30Pressemelding

The Valence Group has provided a fairness opinion to SK Capital Partners, LP in connection with its recapitalization of Archroma, including investments made by various affiliates of SK Capital. Terms of the transaction were not disclosed. About SK Capital SK Capital is a private investment firm focused on the specialty materials, chemicals and pharmaceutical sectors. The firm builds strong and growing businesses that generate substantial long-term value for its investors. SK Capital utilizes its industry, operating and investment experience to identify opportunities to transform businesses into higher performing companies with improved strategic positioning, growth, profitability and risk profiles. The firm currently has approximately $1.9 billion of assets under management and its portfolio companies generate revenues of over $5.0 billion annually and employ approximat

Biker Summer 2017 campaign: What’s happening during Biker Summer 2017? Moto-tyres.co.uk is giving away exciting prizes!18.8.2017 09:22Pressemelding

Whether it’s a short weekend break or a long-distance tour – once again this year Moto-tyres.co.uk is asking bikers from 10 countries about their dream destinations and longest journeys as part of its “Biker Summer 2017” campaign. To ensure than nothing gets in the way of your next tour, the two-wheeler tyre store from Delticom, Europe’s leading online tyre dealer, is entering anyone who completes the survey before 30 September 2017 into a prize draw to win some great biking accessories. Simply answer three short questions about your plans for bike tours this year (don’t forget to provide your name and email address), and with a bit of luck, you might win one of these great prizes. Up for grabs are a GARMIN motorbike GPS system, a GoPro camera with helmet bracket and five 200-Pound vouchers for new motorbike tyres from the online store – thanks to the product range at Moto-tyres.co.uk, eve

Lenovo Continues to Gain Momentum in First Quarter FY 2017/1818.8.2017 00:04Pressemelding

Behind the strength of its 3-wave strategy, Lenovo’s business transformation continued to gain traction during the first quarter, delivering solid profitability in its core PC and smart devices business, and revenue and profit improvements in targeted growth areas, including the data center and mobile businesses. Fueled by new investments in people and products, Lenovo’s Data Center Group (DCG) introduced the most comprehensive product lineup in its history, with the new ThinkSystem and ThinkAgile portfolio, and continued to build out its end-to-end sales organization. Similarly, Lenovo’s Mobile Business Group launched significant new products led by the Moto Z2 Force, available now on all major U.S. carriers, and ramped up its branding efforts worldwide. “In the first quarter this fiscal year, we had stable performance as we executed our 3-wave strategy with commitment. We

Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 15:57Pressemelding

Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio

Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 12:08Pressemelding

On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c

PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 07:00Pressemelding

PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom