Navigation Links
Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With Emphysema
Date:10/22/2007

- Results Presented at CHEST 2007 -

CHICAGO, and REDWOOD CITY, Calif., Oct. 22 /PRNewswire/ -- Emphasys Medical, Inc. today presented positive results from the company's pivotal Endobronchial Valve for Emphysema PalliatioN Trial (VENT), showing that the company's Zephyr(R) Endobronchial Valve (EBV) improved lung function and exercise tolerance in patients with emphysema. These data were presented at the CHEST 2007 meeting in Chicago, Illinois in a symposium titled, "Results of VENT: Endobronchial Valves for Emphysema Palliation Trial," which was co-chaired by Dr. Charlie Strange from the Medical University of South Carolina in Charleston, and Dr. Marc Noppen from the University Hospital AZ-VUB in Brussels Belgium. The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier.

VENT was a randomized, multi-center trial evaluating the efficacy and safety of the Zephyr EBV in 321 patients with severe heterogeneous emphysema. The trial was designed based on input from a panel of expert clinicians convened by the U.S. Food and Drug Administration (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 of its primary efficacy endpoints showing statistically significant improvements in lung function (p=0.0047) and exercise tolerance (p=0.0073). VENT also showed the Zephyr EBV to have a favorable safety profile in terms of 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).

"The positive results of VENT demonstrate that this minimally invasive therapy may improve the quality of life of patients with emphysema and may set the standard for future research in the field of endobronchial valve therapy," said Dr. Strange.

Emphasys recently submitted a pre-market approval (PMA) application to the FDA requesting approval to market the Zephyr EBV in the United States.

About the Emphasys Zephyr(R) EBV

The company's Zephyr(R) 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.

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 and designed to allow 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.

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 products 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:5/24/2016)... Mass. , May 24, 2016  NxStage Medical, ... technology company focused on advancing renal care, today announced ... plans to participate in the following schedule of investor ... be made available at http://ir.nxstage.com/ . ... Jefferies Healthcare Conference NY, NY           Friday, June ...
(Date:5/24/2016)... May 24, 2016 The ... world , s first dual therapy stent, ...   OrbusNeich, a global company specializing in ... portfolio to include products to treat peripheral artery disease. ... first entry devices for lower limb and arteriovenous (AV) ...
(Date:5/24/2016)... 24, 2016 Open Access Journal ... Neurophysiology  Elsevier , a world-leading provider ... today announced the launch of Clinical Neurophysiology ... that focuses on clinical practice issues in clinical neurophysiology. ... series, normal values and didactic reviews. It is an ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... Today American ... Wertheim College of Medicine announced the AUA-FIU Global MD Program. Students in ... Certificate from AUA and a Certificate of Completion from the FIU Herbert Wertheim ...
(Date:5/25/2016)... ... May 25, 2016 , ... CloudLIMS, joins an elite number of companies that ... Providers list of 2016 by CIOReview. , In a deliberate session with the honorary ... Providers 2016 has been concluded with. The positioning is based on evaluation of CloudLIMS’ ...
(Date:5/25/2016)... Livonia, MI (PRWEB) , ... May 25, 2016 , ... ... honors Allstate has to bestow: the Dick McKenna Good Hands Legacy Award. McKenna ran ... commitment to others which continues to inspire all those who knew him. The award ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... solutions to industries ranging from medical and pharmaceutical, to food and HVAC facilities. ... well as on-site training. , For medical applications, Afrimesure offers a variety ...
(Date:5/25/2016)... PA (PRWEB) , ... May 25, 2016 , ... ... announced the results of its annual Medical and Prescription Drug survey , ... benefits. , The survey, which was conducted in December 2015, indicates that ...
Breaking Medicine News(10 mins):