Navigation Links
Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
Date:10/30/2007

REDWOOD CITY, Calif., Oct. 30 /PRNewswire/ -- Emphasys Medical, Inc. today announced that its pre-market approval (PMA) application for the Zephyr(R) Endobronchial Valve (EBV) has been accepted as suitable for filing by the U.S. Food and Drug Administration (FDA) and has been granted expedited review. The Zephyr EBV is a minimally invasive treatment option intended to help patients with emphysema breathe more easily. The FDA granted expedited review based on the potential of endobronchial valve treatment to offer a viable alternative to surgery in some patients for the treatment of emphysema, and the lack of a therapeutic device to address this potentially life-threatening or irreversibly debilitating disease.

Submitted to the FDA in mid-September, the PMA application was based on data from the company's pivotal trial, the Endobronchial Valve for Emphysema PalliatioN Trial (VENT). VENT was a randomized, multi-center trial enrolling 321 patients with severe heterogeneous emphysema. The trial design was based on input from a panel of expert clinicians convened by the FDA in February 2003 to help establish the appropriate clinical endpoints for medical device treatments of emphysema. The VENT study's primary efficacy endpoints were improvement in lung function as measured by forced expiratory volume in one second (change in FEV1) and exercise tolerance as measured by a six minute walk test (6MWT) both at six months. The primary safety endpoint was a composite of major complications at six months.

VENT met both its primary efficacy endpoints showing statistically significant improvements in lung function (p=0.0047) and exercise tolerance (p=0.0073). VENT also showed that the Zephyr EBV has a favorable safety profile in comparing major complications between the treatment and control groups. At the six-month follow-up, protocol-defined major complications occurred in 5.9% of treated patients compared to 1.0% of control patients. The difference did not r
'/>"/>

SOURCE Emphasys Medical, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Gene Chips to Detect CYP Variations: A New Step Toward Customized Medical Therapy.
2. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
3. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
4. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
5. Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical Oncology
6. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference
7. The International Myeloma Foundation Says Data Reported at a Global Medical Meeting in Greece Demonstrates Improved Survival for a Wide Range of Myeloma Patients
8. Algeta Demonstrates Targeted Cancer-killing Potential of Novel Alpha Particle Linked Antibodies in Leading Medical Journal Blood
9. Vical Interim Clinical Results Demonstrate Safety and Tolerability of Inovio Biomedicals Electroporation DNA Delivery Technology
10. Inovio Biomedical Highlights Enhanced DNA Vaccine Potency with Electroporation DNA Delivery Technology and New Devices at Gene Therapy Meeting
11. World First Medical Treatment Announced by Researchers at Queen Mary University London and University of Leicester
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... 10, 2014   LabStyle Innovations Corp . ... announced the appointment of Professor Richard B. ... Board of Directors. Prof. Stone brings ... to LabStyle as an entrepreneur, venture capitalist public, ... governance expert. He currently serves on the board ...
(Date:1/15/2014)... 2014 Most osteoporosis patients want a choice in ... survey* sponsored by Mission Pharmacal Company. The survey, conducted ... online support community, revealed that 74 percent of osteoporosis ... a form other than a pill or a tablet. ...
(Date:1/15/2014)... , Jan. 15, 2014  Celsion Corporation (the "Company") (NASDAQ: ... commitments from institutional investors to purchase an aggregate of ... an at-the-market registered direct offering, led by a dedicated ... definitive purchase agreements with these investors pursuant to which ...
Breaking Medicine Technology:LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 2LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 3LabStyle Innovations Welcomes Richard B. Stone to its Board of Directors 4Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3
(Date:7/11/2014)... Down is a reliable source for cheap Luke Bryan tickets ... years Luke Bryan has been honored by almost every major association ... award shows, but each summer, he hits the road on what ... and this summer is more of the same. When it comes ... success that is currently entitled to Luke Bryan. The native of ...
(Date:7/11/2014)... (PRWEB) July 11, 2014 The ... NMR Spectroscopy, Chromatography, Electrophoresis, Surface Plasmon Resonance, X-ray ... Forecast to 2018", analyzes and studies the major ... Europe, Asia, and the Rest of the World ... growth in the past few years, mainly due ...
(Date:7/11/2014)... July 11, 2014 Experience Mayan heritage ... Heritage Experience Package at the luxury all-inclusive AAA Five ... include a guided on-site ecological family tour where guests ... The Coba Mayan Encounter Tour at the Mayan archeological ... the tallest pyramid in the Yucatan and the only ...
(Date:7/11/2014)... the distinguished wedding dress manufacturer and retailer, has recently ... . To top it all off, all these high ... to 65% off. Clients who place orders on the ... Fadhits.com is devoted to designing and selling beautiful wedding ... All its items come with very fast delivery. More ...
(Date:7/11/2014)... 11, 2014 Emily Johnson, owner of the Portland ... fitness boot camp has held two charity workout events ... Saturday, July 26th, from 7:15 - 8:30 at Col Summers City ... charity boot camp session raised $510 for Medical Teams International. Their ... I Have a Dream. On July 26th, Johnson and Portland ...
Breaking Medicine News(10 mins):Health News:Luke Bryan Tickets Shoreline Amphitheatre in Mountain View, CA: Ticket Down Slashes Ticket Prices for Luke Bryan in Mountain View at the Shoreline Amphitheatre 2Health News:Luke Bryan Tickets Shoreline Amphitheatre in Mountain View, CA: Ticket Down Slashes Ticket Prices for Luke Bryan in Mountain View at the Shoreline Amphitheatre 3Health News:Proteomics Market Worth $20,696.4 Million by 2018 - New Report By MarketsandMarkets 2Health News:Proteomics Market Worth $20,696.4 Million by 2018 - New Report By MarketsandMarkets 3Health News:Proteomics Market Worth $20,696.4 Million by 2018 - New Report By MarketsandMarkets 4Health News:Explore the Aura and Mystery of the Yucatan’s Mayan Culture with New Hotel Package at AAA Five Diamond Grand Velas Riviera Maya 2Health News:Explore the Aura and Mystery of the Yucatan’s Mayan Culture with New Hotel Package at AAA Five Diamond Grand Velas Riviera Maya 3Health News:Elegant Lace Holiday Dresses Released by Fadhits.com 2Health News:Portland Fit Body Boot Camp Invites Public to Fitness Boot Camp Session Benefiting Children’s Cancer Association 2Health News:Portland Fit Body Boot Camp Invites Public to Fitness Boot Camp Session Benefiting Children’s Cancer Association 3
... Feb. 15 (HealthDay News) -- Medical imaging tests are often ... new study suggests. The finding stems from a survey ... imaging tests conducted on 2,068 patients. The researchers found that ... called "defensive purposes" and accounted for about 35 percent of ...
... the "real world" may more effectively prevent cardiovascular ... findings in clinical research settings, according to the ... disease prevention guidelines for women., First published in ... based on findings observed in clinical research. That ...
... A mini exercise bike that can be used while working at ... others with sedentary jobs, according to a new study. The ... in front of most office chairs and used while a person ... 40 years old, on average. They spent at least 75 percent ...
... MONDAY, Feb. 14 (HealthDay News) -- Adults who experience hearing ... Alzheimer,s disease than those who don,t suffer hearing loss, new ... the risk, the study suggested. "This work suggests that ... an adult and the likelihood of developing cognitive decline with ...
... (HealthDay News) -- Heart disease patients are far more likely ... referral after discussing the matter with their doctor, a new ... and death by about 25 percent over one to two ... disease patients in Canada, the United States and United Kingdom ...
... HealthDay Reporter , MONDAY, Feb. 14 (HealthDay News) -- Most ... Administration for posing life-threatening or serious safety risks were initially ... approval process, new research reveals. The findings call out ... products from reaching the market in the first place, said ...
Cached Medicine News:Health News:Fear of Lawsuits May Be Leading to Extra Medical Tests 2Health News:Updated heart disease prevention guidelines for women focus more on 'real-world' recommendations 2Health News:Updated heart disease prevention guidelines for women focus more on 'real-world' recommendations 3Health News:Study Suggests Hearing Loss-Dementia Link 2Health News:Study Suggests Hearing Loss-Dementia Link 3Health News:Too Few Heart Patients Go to Cardiac Rehab 2Health News:Report Blames Speedy FDA Clearance for Medical Device Recalls 2Health News:Report Blames Speedy FDA Clearance for Medical Device Recalls 3
The Pneumatic Consulting Otoscope provides two viewing lenses for dual observation of the tympanic membrane. Sealed system for pneumnatic otoscopy and rotatable head for left- and right-sided viewin...
Provides bright output and rotating lens with ultra-seal for pneumatic otoscopy....
... Cryotome FE and FSE are a new ... The microtome is outside of the cryochamber, ... well as faster temperature adjustment. Simple, multi-lingual ... temperature controls on the main touch-screen display. ...
... When it comes to laser treatment ... choroidal neovascularization,(CNV), nothing compares to the ... use with Visudyne (verteporfin for injection) ... wont find on any other laserfeatures,that ...
Medicine Products: