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 reach statistical significance. Investigators also reported on select patient subsets. In patients defined as having physiologically isolated target lung zones and correct Zephyr EBV placement, FEV1 was increased by 21% (p<0.0001).

While the PMA was granted expedited review, such grant does not change the standards associated with obtaining FDA approval, which the company will have to satisfy, and does not imply that the FDA has performed an in-depth evaluation of the safety and effectiveness of the Zephyr EBV.

About the Zephyr Endobronchial Valve

The Zephyr EBV is a small one-way silicone valve that is inserted into airways to prevent air from entering the diseased portion of the lung during inhalation, while allowing air and fluids to escape during exhalation. The Zephyr EBV is intended to mitigate the effects of emphysema by isolating the targeted diseased portion of the lung, causing a reduction in volume of the diseased region and allowing the healthier portions of the lung to function more normally. The Zephyr EBV has also been used for the treatment of lung air leaks in limited circumstances under a compassionate use protocol approved by the FDA on a case-by-case basis. Procedures using the Zephyr EBV are potentially reversible, if necessary, and the valves can be removed with standard bronchoscopic tools.

The Zephyr EBV is CE marked and has been sold on a limited basis in Europe and in certain Asia-Pacific regions including Australia, Hong Kong and Singapore. The Zephyr EBV system is limited to investigational use in the United States.

About Emphasys Medical

Based in Redwood City, California, Emphasys Medical is a medical technology company focused on developing and commercializing therapeutic devices for the treatment of patients with emphysema and other debilitating breathing disorders.

This press release contains statements that are forward-looking in nature. Statements preceded by the words believe, expect, anticipate, plan, intend, continue, estimate, may, will, and similar expressions are forward-looking statements. Forward-looking statements are based on the Company's beliefs and assumptions based on information available at the time the assumption was made. Forward-looking statements relate to, among other things, strategies, development timelines, regulatory developments and the timing and likelihood of commercialization of our product candidates, relating to the Company. By its nature, such forward-looking information is subject to various risks and uncertainties which could cause the Company's actual results and experience to differ materially from the anticipated results or other expectations expressed. Readers are cautioned not to place undue reliance on this forward- looking information, which is given as of the date it is expressed in this document, and the Company undertakes no obligation to update publicly or revise any forward looking information, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Emphasys Medical, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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:2/11/2016)... -- - Cardiac Marker Diagnostic Testing ... Cancer Therapy. - European Point of Care Diagnostic ... - Key Diagnostic Testing Markets. - Molecular Diagnostics ... Testing. - Molecular Diagnostics in Infectious Disease Testing. ... Products World Markets. - Point of Care Diagnostic ...
(Date:2/11/2016)... Feb. 11, 2016 Stem cells are primitive ... by self-renewal and the capacity to differentiate into mature ... discovery, as the first mouse embryonic stem cells were ... until 1995 that the first culturing of embryonic stem ... were not produced until 2006 As a result of ...
(Date:2/11/2016)... 11, 2016 Laboratory glassware and ... laboratories. These may range from microscope slides to large ... made from borosilicate glass because of its low weight ... other hand, started gaining popularity over the past decade ... replace glass with plastic in several applications due to ...
Breaking Medicine Technology:
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... ... School of Nursing with an in-kind gift of a VeinViewer® Vision vein ... as they learn how to start an IV and draw blood, combining technology ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi ... Management Solution Providers list for its expertise in eClinical Solutions. DDi has built ... serve the technology needs of global clients. DDi provides smarter technology for Clinical ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & ... purpose of these scholarships is to encourage applicants to pursue a degree in their ... these two parishes. , “We have available jobs in St. Landry and Evangeline ...
(Date:2/12/2016)... ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to the Future , ... , As Winston Churchill said, “Those who don’t learn from history are doomed to ... expect when they come knocking this year. But that takes time. , Take a ...
(Date:2/12/2016)... , ... February 12, 2016 , ... As a former ... schedule, a demanding job, and no time to decompress, Rabinowitz found herself drawn to ... to meditation for its impact on her life, implementing a 20-minute-per-day meditation practice with ...
Breaking Medicine News(10 mins):